Clinical Trials Register

Summary
EudraCT Number:	2021-002329-56
Sponsor's Protocol Code Number:	FISIO
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-25
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-002329-56

A.3

Full title of the trial

Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilation.

Estudio exploratorio para evaluar la eficacia y seguridad de la administración en la nutrición de 1,5 g de proteína/kg/día frente a 1,0 g de proteína/kg/día en la fase catabólica del paciente crítico bajo ventilación mecánica.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

efficacy and safety of administering elevated levels of prOteins to critically ill patients prOteins

eFIcacia y Seguridad de la administración de nIveles elevados de prOteínas a pacientes críticos

A.4.1

Sponsor's protocol code number

FISIO

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fresenius Kabi
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
B.5.2	Functional name of contact point	María del Carmen Sánchez Álvarez
B.5.3	Address:
B.5.3.1	Street Address	Paseo de la R. Cristina, 36
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28014
B.5.3.4	Country	Spain
B.5.4	Telephone number	34915021213
B.5.6	E-mail	secretaria@semicyuc.org

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SmofKaviben Central
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI ESPAÑA. S.A.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SmofKaviben Central
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Parenteral use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALANINE
D.3.9.1	CAS number	56-41-7
D.3.9.2	Current sponsor code	ALANINE
D.3.9.3	Other descriptive name	ALANINE
D.3.9.4	EV Substance Code	SUB05290MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3.5 to 17.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ARGININE
D.3.9.1	CAS number	74-79-3
D.3.9.2	Current sponsor code	ARGININE
D.3.9.3	Other descriptive name	ARGININE
D.3.9.4	EV Substance Code	SUB05560MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3.0 to 15.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLYCINE
D.3.9.1	CAS number	56-40-6
D.3.9.2	Current sponsor code	GLYCINE
D.3.9.3	Other descriptive name	GLYCINE
D.3.9.4	EV Substance Code	SUB12000MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.8 to 13.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HISTIDINE
D.3.9.1	CAS number	71-00-1
D.3.9.2	Current sponsor code	HISTIDINE
D.3.9.3	Other descriptive name	HISTIDINE
D.3.9.4	EV Substance Code	SUB08045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.8 to 3.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ISOLEUCINE
D.3.9.1	CAS number	73-32-5
D.3.9.2	Current sponsor code	ISOLEUCINE
D.3.9.3	Other descriptive name	ISOLEUCINE
D.3.9.4	EV Substance Code	SUB08320MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.3 to 6.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUCINE
D.3.9.1	CAS number	61-90-5
D.3.9.2	Current sponsor code	LEUCINE
D.3.9.3	Other descriptive name	LEUCINE
D.3.9.4	EV Substance Code	SUB08446MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.9 to 9.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LYSINE ACETATE
D.3.9.1	CAS number	57282-49-2
D.3.9.2	Current sponsor code	LYSINE ACETATE
D.3.9.3	Other descriptive name	LYSINE ACETATE
D.3.9.4	EV Substance Code	SUB21782
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.7 to 8.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METHIONINE
D.3.9.1	CAS number	63-68-3
D.3.9.2	Current sponsor code	METHIONINE
D.3.9.3	Other descriptive name	METHIONINE
D.3.9.4	EV Substance Code	SUB08850MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.1 to 5.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHENYLALANINE
D.3.9.1	CAS number	63-91-2
D.3.9.2	Current sponsor code	PHENYLALANINE
D.3.9.3	Other descriptive name	PHENYLALANINE
D.3.9.4	EV Substance Code	SUB09786MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.3 to 6.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PROLINE
D.3.9.1	CAS number	147-85-3
D.3.9.2	Current sponsor code	PROLINE
D.3.9.3	Other descriptive name	PROLINE
D.3.9.4	EV Substance Code	SUB10082MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.8 to 14.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SERINE
D.3.9.1	CAS number	56-45-1
D.3.9.2	Current sponsor code	SERINE
D.3.9.3	Other descriptive name	SERINE
D.3.9.4	EV Substance Code	SUB10494MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.6 to 8.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAURINE
D.3.9.1	CAS number	107-35-7
D.3.9.2	Current sponsor code	TAURINE
D.3.9.3	Other descriptive name	TAURINE
D.3.9.4	EV Substance Code	SUB10836MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.25 to 1.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	THREONINE
D.3.9.1	CAS number	72-19-5
D.3.9.2	Current sponsor code	THREONINE
D.3.9.3	Other descriptive name	THREONINE
D.3.9.4	EV Substance Code	SUB10989MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.1 to 5.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRYPTOPHAN
D.3.9.1	CAS number	73-22-3
D.3.9.2	Current sponsor code	TRYPTOPHAN
D.3.9.3	Other descriptive name	TRYPTOPHAN
D.3.9.4	EV Substance Code	SUB12377MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.5 to 2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TYROSINE
D.3.9.1	CAS number	60-18-4
D.3.9.2	Current sponsor code	TYROSINE
D.3.9.3	Other descriptive name	TYROSINE
D.3.9.4	EV Substance Code	SUB11371MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.10 to 0.49
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VALINE
D.3.9.1	CAS number	72-18-4
D.3.9.2	Current sponsor code	VALINE
D.3.9.3	Other descriptive name	VALINE
D.3.9.4	EV Substance Code	SUB00008MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.6 to 7.6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIUM CHLORIDE
D.3.9.1	CAS number	10043-52-4
D.3.9.2	Current sponsor code	CALCIUM CHLORIDE
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB11767MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.14 to 0.69
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.1	CAS number	1334-74-3
D.3.9.2	Current sponsor code	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.3	Other descriptive name	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.4	EV Substance Code	SUB90005
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.1 to 5.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIUM SULFATE HEPTAHYDRATE
D.3.9.1	CAS number	10034-99-8
D.3.9.2	Current sponsor code	MAGNESIUM SULFATE HEPTAHYDRATE
D.3.9.3	Other descriptive name	MAGNESIUM SULFATE HEPTAHYDRATE
D.3.9.4	EV Substance Code	SUB14449MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.30 to 1.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium chloride
D.3.9.1	CAS number	7447-40-7
D.3.9.2	Current sponsor code	Potassium chloride
D.3.9.3	Other descriptive name	Potassium chloride
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.1 to 5.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ACETATE TRIHYDRATE
D.3.9.1	CAS number	6131-90-4
D.3.9.2	Current sponsor code	SODIUM ACETATE TRIHYDRATE
D.3.9.3	Other descriptive name	SODIUM ACETATE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB15266MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.9 to 4.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ZINC SULFATE HEPTAHYDRATE PH. EUR.
D.3.9.1	CAS number	7446-20-0
D.3.9.2	Current sponsor code	ZINC SULFATE HEPTAHYDRATE PH. EUR.
D.3.9.3	Other descriptive name	ZINC SULFATE HEPTAHYDRATE PH. EUR.
D.3.9.4	EV Substance Code	SUB198637
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.0033 to 0.016
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLUCOSE MONOHYDRATE
D.3.9.1	CAS number	14431-43-7
D.3.9.2	Current sponsor code	GLUCOSE MONOHYDRATE
D.3.9.3	Other descriptive name	GLUCOSE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB13983MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	63 to 313
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SOYA-BEAN OIL REFINED
D.3.9.1	CAS number	8001-22-7
D.3.9.2	Current sponsor code	SOYA-BEAN OIL REFINED
D.3.9.3	Other descriptive name	SOYA-BEAN OIL REFINED
D.3.9.4	EV Substance Code	SUB12326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5.6 to 28.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIGLYCERIDES, MEDIUM CHAIN
D.3.9.1	CAS number	73398-61-5
D.3.9.2	Current sponsor code	TRIGLYCERIDES, MEDIUM CHAIN
D.3.9.3	Other descriptive name	TRIGLYCERIDES, MEDIUM CHAIN
D.3.9.4	EV Substance Code	SUB12373MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5.6 to 28.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OLIVE OIL, REFINED
D.3.9.1	CAS number	8001-25-0
D.3.9.2	Current sponsor code	OLIVE OIL, REFINED
D.3.9.3	Other descriptive name	OLIVE OIL, REFINED
D.3.9.4	EV Substance Code	SUB12186MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.7 to 23.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FISH OIL, RICH IN OMEGA-3-ACIDS
D.3.9.1	CAS number	8002-50-4
D.3.9.2	Current sponsor code	FISH OIL, RICH IN OMEGA-3-ACIDS
D.3.9.3	Other descriptive name	FISH OIL, RICH IN OMEGA-3-ACIDS
D.3.9.4	EV Substance Code	SUB90503
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.8 to 14.0
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SmofKabiven extra Nitrogen
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI ESPAÑA. S.A.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SmofKabiven extra Nitrogen
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Parenteral use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALANINE
D.3.9.1	CAS number	56-41-7
D.3.9.2	Current sponsor code	ALANINE
D.3.9.3	Other descriptive name	ALANINE
D.3.9.4	EV Substance Code	SUB05290MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.6 to 23
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ARGININE
D.3.9.1	CAS number	74-79-3
D.3.9.2	Current sponsor code	ARGININE
D.3.9.3	Other descriptive name	ARGININE
D.3.9.4	EV Substance Code	SUB05560MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.0 to 20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLYCINE
D.3.9.1	CAS number	56-40-6
D.3.9.2	Current sponsor code	GLYCINE
D.3.9.3	Other descriptive name	GLYCINE
D.3.9.4	EV Substance Code	SUB12000MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3.6 to 18
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HISTIDINE
D.3.9.1	CAS number	71-00-1
D.3.9.2	Current sponsor code	HISTIDINE
D.3.9.3	Other descriptive name	HISTIDINE
D.3.9.4	EV Substance Code	SUB08045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.0 to 5.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ISOLEUCINE
D.3.9.1	CAS number	73-32-5
D.3.9.2	Current sponsor code	ISOLEUCINE
D.3.9.3	Other descriptive name	ISOLEUCINE
D.3.9.4	EV Substance Code	SUB08320MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.7 to 8.3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUCINE
D.3.9.1	CAS number	61-90-5
D.3.9.2	Current sponsor code	LEUCINE
D.3.9.3	Other descriptive name	LEUCINE
D.3.9.4	EV Substance Code	SUB08446MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.4 to 12
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LYSINE ACETATE
D.3.9.1	CAS number	57282-49-2
D.3.9.2	Current sponsor code	LYSINE ACETATE
D.3.9.3	Other descriptive name	LYSINE ACETATE
D.3.9.4	EV Substance Code	SUB21782
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.2 to 11
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METHIONINE
D.3.9.1	CAS number	63-68-3
D.3.9.2	Current sponsor code	METHIONINE
D.3.9.3	Other descriptive name	METHIONINE
D.3.9.4	EV Substance Code	SUB08850MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.4 to 7.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHENYLALANINE
D.3.9.1	CAS number	63-91-2
D.3.9.2	Current sponsor code	PHENYLALANINE
D.3.9.3	Other descriptive name	PHENYLALANINE
D.3.9.4	EV Substance Code	SUB09786MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.7 to 8.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PROLINE
D.3.9.1	CAS number	147-85-3
D.3.9.2	Current sponsor code	PROLINE
D.3.9.3	Other descriptive name	PROLINE
D.3.9.4	EV Substance Code	SUB10082MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3.7 to 19
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SERINE
D.3.9.1	CAS number	56-45-1
D.3.9.2	Current sponsor code	SERINE
D.3.9.3	Other descriptive name	SERINE
D.3.9.4	EV Substance Code	SUB10494MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.2 to 11
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAURINE
D.3.9.1	CAS number	107-35-7
D.3.9.2	Current sponsor code	TAURINE
D.3.9.3	Other descriptive name	TAURINE
D.3.9.4	EV Substance Code	SUB10836MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.33 to 1.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	THREONINE
D.3.9.1	CAS number	72-19-5
D.3.9.2	Current sponsor code	THREONINE
D.3.9.3	Other descriptive name	THREONINE
D.3.9.4	EV Substance Code	SUB10989MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.5 to 7.3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRYPTOPHAN
D.3.9.1	CAS number	73-22-3
D.3.9.2	Current sponsor code	TRYPTOPHAN
D.3.9.3	Other descriptive name	TRYPTOPHAN
D.3.9.4	EV Substance Code	SUB12377MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.66 to 3.3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TYROSINE
D.3.9.1	CAS number	60-18-4
D.3.9.2	Current sponsor code	TYROSINE
D.3.9.3	Other descriptive name	TYROSINE
D.3.9.4	EV Substance Code	SUB11371MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.13 to 0.66
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VALINE
D.3.9.1	CAS number	72-18-4
D.3.9.2	Current sponsor code	VALINE
D.3.9.3	Other descriptive name	VALINE
D.3.9.4	EV Substance Code	SUB00008MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.1 to 10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Calcium chloride dihydrate
D.3.9.1	CAS number	10035-04-8
D.3.9.2	Current sponsor code	Calcium chloride dihydrate
D.3.9.3	Other descriptive name	Calcium chloride dihydrate
D.3.9.4	EV Substance Code	SUB12664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.14 to 0.72
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.1	CAS number	1334-74-3
D.3.9.2	Current sponsor code	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.3	Other descriptive name	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.4	EV Substance Code	SUB90005
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.2 to 5.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIUM SULFATE HEPTAHYDRATE
D.3.9.1	CAS number	10034-99-8
D.3.9.2	Current sponsor code	MAGNESIUM SULFATE HEPTAHYDRATE
D.3.9.3	Other descriptive name	MAGNESIUM SULFATE HEPTAHYDRATE
D.3.9.4	EV Substance Code	SUB14449MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.31 to 1.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium chloride
D.3.9.1	CAS number	7447-40-7
D.3.9.2	Current sponsor code	Potassium chloride
D.3.9.3	Other descriptive name	Potassium chloride
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.2 to 5.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ACETATE TRIHYDRATE
D.3.9.1	CAS number	127-09-3
D.3.9.2	Current sponsor code	SODIUM ACETATE TRIHYDRATE
D.3.9.3	Other descriptive name	SODIUM ACETATE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB15266MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.82 to 4.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ZINC SULFATE HEPTAHYDRATE PH. EUR.
D.3.9.1	CAS number	7446-19-7
D.3.9.2	Current sponsor code	ZINC SULFATE HEPTAHYDRATE PH. EUR.
D.3.9.3	Other descriptive name	ZINC SULFATE HEPTAHYDRATE PH. EUR.
D.3.9.4	EV Substance Code	SUB198637
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.0033 to 0.017
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLUCOSE MONOHYDRATE
D.3.9.1	CAS number	14431-43-7
D.3.9.2	Current sponsor code	GLUCOSE MONOHYDRATE
D.3.9.3	Other descriptive name	GLUCOSE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB13983MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	43 to 214
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SOYA-BEAN OIL REFINED
D.3.9.1	CAS number	8001-22-7
D.3.9.2	Current sponsor code	SOYA-BEAN OIL REFINED
D.3.9.3	Other descriptive name	SOYA-BEAN OIL REFINED
D.3.9.4	EV Substance Code	SUB12326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.4 to 22
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIGLYCERIDES, MEDIUM CHAIN
D.3.9.1	CAS number	73398-61-5
D.3.9.2	Current sponsor code	TRIGLYCERIDES, MEDIUM CHAIN
D.3.9.3	Other descriptive name	TRIGLYCERIDES, MEDIUM CHAIN
D.3.9.4	EV Substance Code	SUB12373MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.4 to 22
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OLIVE OIL, REFINED
D.3.9.1	CAS number	8001-25-0
D.3.9.2	Current sponsor code	OLIVE OIL, REFINED
D.3.9.3	Other descriptive name	OLIVE OIL, REFINED
D.3.9.4	EV Substance Code	SUB12186MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3.7 to 18
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FISH OIL, RICH IN OMEGA-3-ACIDS
D.3.9.1	CAS number	8002-50-4
D.3.9.2	Current sponsor code	FISH OIL, RICH IN OMEGA-3-ACIDS
D.3.9.3	Other descriptive name	FISH OIL, RICH IN OMEGA-3-ACIDS
D.3.9.4	EV Substance Code	SUB90503
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.2 to 11
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.

Debilidad Adquirida en Unidad de Cuidados Intensivos (DAUCI) del paciente crítico

E.1.1.1

Medical condition in easily understood language

Acquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.

Debilidad Adquirida en Unidad de Cuidados Intensivos (DAUCI) del paciente crítico

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10077255
E.1.2	Term	Intensive care unit acquired weakness
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the occurrence and degree of Acquired Acute Critical Care Unit Weakness (ICUCI or ICUAW) in 2 groups of patients treated with different doses of protein (1.5.g/kg/day vs. 1.0 g/kg/day).

Comparar la aparición y grado de Debilidad Adquirida en Unidad de Cuidados Intensivos del paciente crítico (DAUCI o ICUAW), en 2 grupos de pacientes tratados con distintas dosis de proteínas (1.5.g/kg/día vs 1.0 g/kg/día).

E.2.2

Secondary objectives of the trial

To compare the rate of:

- Infectious complications appeared in each of the two groups.
- Days of mechanical ventilation
- Metabolic and/or gastrointestinal complications
- Intra-ICU, in-hospital, 30 and 90 day mortality
- Intra-ICU and hospital days
- Urinary nitrogen excretion during time in ICU
- Quality of life at hospital discharge and 90 days

Comparar la tasa de:

• Complicaciones infecciosas aparecidas en cada uno de los dos grupos
• Días de ventilación mecánica
• Complicaciones metabólicas y/o gastrointestinales
• Mortalidad intra UCI, hospitalaria, 30 y 90 días
• Días de estancia intra UCI y hospitalaria
• Excreción de nitrógeno urinario durante el tiempo en UCI
• Calidad de vida al alta hospitalaria y 90 días

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Must meet all criteria for inclusion:
1. Critically ill patient, adult > 18 years of age.
2. Admission to the ICU during the previous 48 hours.
3. Patients on invasive mechanical ventilation with a minimum expected duration of > 3 days.
4. Patient with a minimum expected duration of clinical nutrition of > 7 days from 48 hours after admission.
5. Written informed consent from the patient or the patient's legal representative or deferred written consent from the patient or the patient's legal representative.
6. Central venous access available for continuous infusion of study drugs.

Deben cumplir todos los criterios para su inclusión:
1. Paciente crítico, adulto > 18 años.
2. Ingreso en la UCI durante las 48 horas previas.
3. Pacientes en ventilación mecánica invasiva con una duración mínima esperada de > 3 días.
4. Paciente con una duración mínima esperada de la nutrición clínica de > 7 días a partir de las 48 horas siguientes a la admisión.
5. Consentimiento informado por escrito del paciente o del representante legal del paciente o consentimiento escrito diferido del paciente o del representante legal del paciente.
6. Acceso venoso central disponible para la infusión continua de los fármacos del estudio.

E.4

Principal exclusion criteria

1. Refusal of informed consent
2. Acute renal failure (renal injury stage of 3)
3. Hepatic failure (cirrhosis or Chilg-Pugh Scale > 5).
4. Severe hepatic insufficiency with INR > 1.7 (prothrombin time < 50%) and encephalopathy.
5. Patients with COVID-19
6. Body Mass Index (BMI) > 40 or < 18.5 (morbid obesity or previous caloric malnutrition)
7. Pregnant patients
8. CNS pathologies (Glasgow < 6)
9. Peripheral SN pathologies
10. Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests.
11. Severe muscular pathology
12. Participation in another clinical trial
13. Usual residence outside the region (impossibility of contact after discharge from the ICU).
14. Known hypersensitivity to milk protein or to any substance contained in Fresubin®.
15. Any congenital error in the metabolism of amino acids.
16. Previous inclusion in the present study

1. Deniegan consentimiento informado
2. Insuficiencia renal aguda (estadio de lesión renal de 3)
3. Insuficiencia hepática (cirrosis o Escala Chilg-Pugh > 5)
4. Insuficiencia hepática grave con INR > 1,7 (tiempo de protrombina < 50%) y encefalopatía
5. Pacientes con COVID-19
6. Índice de Masa Corporal (IMC) > 40 o < 18,5 (obesidad mórbida o malnutrición previa calórica)
7. Pacientes embarazadas
8. Patologías SNC (Glasgow < 6)
9. Patologías del SN periférico
10. Pacientes con disfunción cognitiva/demencia o incapaces de seguir las instrucciones respecto a las pruebas MRC
11. Patología muscular grave
12. Participación en otro ensayo clínico
13. Residencia habitual fuera de la región (imposibilidad de contactar tras salida de UCI)
14. Hipersensibilidad conocida a la proteína de la leche o a cualquier sustancia contenida en Fresubin®
15. Cualquier error congénito en el metabolismo de los aminoácidos
16. Inclusión previa en el presente estudio

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint will be Intensive Care Unit-Acquired Acute Care Weakness (ICUAW) as defined by a Medical Research Council (MRC Scale) score of less than 48, measured from ventilator weaning, every 4-6 days, on day 28 or at ICU discharge. (ANNEXES 4 and 4a)

El criterio de valoración principal será la Debilidad Adquirida en Cuidados Intensivos (DAUCI) (o Intensive Care Unit-Acquired Weakness [ICUAW]) definida por una puntuación del Medical Research Council (Escala MRC) de menos de 48, medida desde el destete del respirador, cada 4-6 días, el día 28 o en el momento del alta de la UCI. (ANEXOS 4 y 4 a)

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 4-6 days, on day 28 or at ICU discharge.

Cada 4-6 días, el día 28 o en el momento del alta de la UCI.

E.5.2

Secondary end point(s)

Secondary objectives will be studied by:

- Muscle strength will be measured by Dynamometry ICU, Hospital and at 90 days, and mobility will be measured by IMS (Intensive Mobility Scale) at ICU discharge, hospital discharge and at 90 days. (ANNEX 5)

- Incidence of new nosocomial infections (as defined by the Centers for Disease Control and Prevention (CDC). (ANNEX 6)

- Surgical wound infection
- Primary bacteremia
- Cardiovascular system infection
- Central nervous system infection
- Gastrointestinal Tract Infection
- Skin and soft tissue infection
- Pneumonia associated with mechanical ventilation
- Lower respiratory tract infection without evidence of pneumonia (tracheobronchitis)
- Urinary tract infection
- Sinusitis

- Duration and type of infection. (Onset and end)
- Days of mechanical ventilation
- ICU and hospital stay days
- Mortality (ICU, hospital, 90 days)

Los objetivos secundarios se estudiarán mediante:

- La fuerza muscular se medirá mediante Dinamometría UCI, Hospital y a los 90 días, y la movilidad se medirá mediante la IMS (Intensive Mobility Scale) al alta de UCI, al alta hospitalaria y a 90 días. (ANEXO 5)

- Incidencia de nuevas infecciones nosocomiales (según definición de Centers for disease control and prevention (CDC). (ANEXO 6)

• Infección de herida quirúrgica
• Bacteriemia primaria
• Infección del sistema cardiovascular
• Infección del sistema nervioso central
• Infección del tracto gastrointestinal
• Infección de piel y tejidos blandos
• Neumonía asociada a ventilación mecánica
• Infección del tracto respiratorio inferior sin evidencia de neumonía (traqueobronquitis)
• Infección del tracto urinario
• Sinusitis

- Duración y tipo de infección. (Inicio y final)
- Días de la ventilación mecánica
- Días de la estancia en UCI y hospitalaria
- Mortalidad (UCI, hospital, 90 días)

E.5.2.1

Timepoint(s) of evaluation of this end point

At ICU discharge, hospital discharge and at 90 days.

Al alta de UCI, al alta hospitalaria y a 90 días.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The study will terminate if exitus or 90 days after the start of the intervention.

El estudio terminará si éxitus o a los 90 días del inicio de la intervención

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-25.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patients on invasive mechanical ventilation

Pacientes en ventilación mecánica invasiva

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Best supportive care

Mejores cuidados disponibles

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-15

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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