Clinical Trials Register

Summary
EudraCT Number:	2018-001582-16
Sponsor's Protocol Code Number:	RF-2016-02361583
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-03-18
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-001582-16

A.3

Full title of the trial

Efficacy of Albumin Replacement and Balanced Crystalloid Solutions in Septic Shock (the ALBIOSS-BALANCED trial): a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial.

A.3.1

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

A large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low-chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol – BAL) in septic shock.

Studio multicentrico randomizzato su albumina e soluzioni bilanciate in pazienti con shock settico

A.3.2

Name or abbreviated title of the trial where available

ALBIOSS-BALANCED

A.4.1

Sponsor's protocol code number

RF-2016-02361583

A.5.4

Other Identifiers

Name:

ALBIOSS-BALANCED

Number:

RF-2016-02361583

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	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
B.1.3.4	Country	Italy
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	MINISTERO DELLA SALUTE BANDO 2016
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
B.5.2	Functional name of contact point	DIP. DI RICERCA CARDIOVASCOLA
B.5.3	Address:
B.5.3.1	Street Address	VIA LA MASA, 19
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20156
B.5.3.4	Country	Italy
B.5.4	Telephone number	0239014454
B.5.5	Fax number	0233200049
B.5.6	E-mail	roberto.latinii@marionegri.it

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	ALBUMINA GRIFOLS - 20 G/100 ML SOLUZIONE PER INFUSIONE FLACONE DA 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	INSTITUTO GRIFOLS S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	RINGER LATTATO S.A.L.F. - SOLUZIONE PER INFUSIONE 1 FLACONCINO 500 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	S.A.L.F. SPA LABORATORIO FARMACOLOGICO
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 3
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	RINGER ACETATO LDB - SOLUZIONE PER INFUSIONE FLACONCINO 500 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORI DIACO BIOMEDICALI S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 4
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	CRYSTALSOL - SOLUZIONE PER INFUSIONE 20 SACCHE IN PO/PA DA 500 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Septic shock

Shock settico

E.1.1.1

Medical condition in easily understood language

Septic shock

Shock settico

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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	10040070
E.1.2	Term	Septic shock
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

In the current study, in patients with septic shock, we aim to investigate whether: 1) albumin in addition to crystalloids vs crystalloids alone reduces 90-day mortality (Aim 1); 2) BAL solutions reduces 90-day mortality and/or the incidence of AKI as compared to normal saline (NS) (Aim 2).

Nel presente studio, in pazienti con shock settico, ci proponiamo di studiare se: 1) la somministrazione di albumina in aggiunta a cristalloidi, rispetto all’utilizzo dei soli cristalloidi riduce la mortalità a 90 giorni (Obiettivo 1); l’utilizzo di soluzioni cristalloidi bilanciate (BAL) riduce la mortalità a 90 giorni o l’incidenza di insufficienza renale acuta, rispetto all’utilizzo di Soluzione Fisiologica (NS) (Obiettivo 2).

E.2.2

Secondary objectives of the trial

Aim 1
• ICU mortality
• In-hospital mortality
• 1-year mortality
• Severity and incidence of organ failures, as assessed by the SOFA score
• Incidence of AKI, as assessed by the KDIGO criteria
• Use of renal replacement therapy (RRT) during ICU stay
• Duration of the need for vasopressors during ICU stay
• Duration of mechanical ventilation during ICU stay
• Incidence of secondary-acquired infections during ICU stay
• Length of stay in ICU
• Length of stay in Hospital
Aim 2
• 90-day mortality
• Incidence of AKI, as assessed by the KDIGO criteria
• ICU mortality
• In-hospital mortality
• 1-year mortality
• Severity and incidence of organ failures, as assessed by the SOFA score
• Use of renal replacement therapy (RRT) during ICU stay
• Incidence of severe metabolic acidosis
• Incidence of severe hyperkalemia
• Duration of mechanical ventilation
• Length of stay in ICU
• Length of stay in Hospital

Obiettivo 1
• Mortalità in Terapia Intensiva
• Mortalità intra-ospedaliera
• Mortalità a 1 anno
• Gravità e incidenza di insufficienze d’organo, valutate con SOFA
• Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
• Uso di tecniche di depurazione renale durante degenza in Terapia Intensiva
• Durata della necessità di farmaci vasopressori durante degenza in Terapia Intensiva
• Durata della ventilazione meccanica durante degenza in Terapia Intensiva
• Incidenza di infezioni secondarie acquisite, durante degenza in Terapia Intensiva
• Durata della degenza in Terapia Intensiva
• Durata della degenza ospedaliera
Obiettivo 2
• Mortalità a 90 giorni
• Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
• Mortalità in Terapia Intensiva
• Mortalità intra-ospedaliera
• Mortalità a 1 anno
• Gravità e incidenza di insufficienze d’organo, valutate con SOFA
• Uso di tecniche di depurazione renale durante degenza in Ti
• Durata ospedalizzazione

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients will be enrolled if they meet the two following criteria:
1) Presence of an infection (known or suspected) in at least one site:
a) Lung
b) Abdomen
c) Urinary tract
d) Others (blood, skin and soft tissues, central nervous
system, bones and joints, cardiac system,
reproductive organs)
2) Presence of a severe and acute, sepsis-related
cardiovascular failure, requiring vasopressor to maintain mean arterial pressure >= 65 mmHg, despite adequate volume resuscitation
a) Cardiovascular SOFA score > 2 (3 or 4)

1) Presenza di una certa o sospetta infezione in almeno una
sede:
a) Polmone
b) Addome
c) Trattogenito-urinario
d) Altro (sangue, tessuti molli, sistema nervoso centrale,
apparato osteoarticolare, sistema cardiaco, organi
riproduttivi)
2) Presenza di una grave ed acuta insufficienza cardiovascolare sepsi-correlata, necessitante l’utilizzo di farmaci vasopressori per mantenere una pressione arteriosa media>= 65 mmHg, nonostante un adeguato rimpiazzo volemico.
a) Punteggio cardiovascolare SOFA > 2 (3 o 4)

E.4

Principal exclusion criteria

1)Age < 18 years
2)Moribund state
3)Known or suspected adverse reaction to albumin administration
4)Severe sepsis or septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected)
5) Severe congestive heart failure (NYHA III and IV classes)
6) Clinical situations in which the use of albumin is known or supposed to be
clinically effective (hepatic cirrhosis with ascites, malabsorption syndrome or
protein-losing enteropathy, nephrotic syndrome, burns)
7) More than 24 hours after the onset of septic shock
8) Religious objection to the administration of human blood products
9) Presence of chronic end-stage renal disease
10)Severe hyperkalemia
11)Enrollment in other experimental studies

1) Età inferiore ai 18 anni
2) Stato terminale
3) Reazione allergica nota o sospetta alla somministrazione di albumina
4) Shock settico in pazienti con trauma cerebrale o lesione cerebrale nota o sospetta, clinicamente attiva
5) Severa Insufficienza cardiaca congestizia (classe NYHA III e IV)
6) Situazioni cliniche in cui l’utilizzo di albumina è di provata o supposta efficacia clinica (cirrosi epatica ascitogena, sindrome da malassorbimento o da proteino-dispersione intestinale, sindrome nefrosica, ustioni estese)
7) Passate più di 24 ore dall’insorgenza dello shock settico
8) Obiezione religiosa alla somministrazione di emocomponenti umani
9) Presenza di insufficienza renale cronica terminale
10) Grave iperkalemia
11) Inclusione in altri studi sperimentali

E.5 End points

E.5.1

Primary end point(s)

All-cause 90-day mortality (Aim 1), and a combined primary endpoint including 90-day mortality and/or incidence of AKI during the study (Aim 2).

Mortalità per ogni causa a 90 giorni (Obiettivo 1), e la combinazione di mortalità per ogni causa a 90 giorni e/o l’incidenza di insufficienza renale acuta durante lo studio (Obiettivo 2).

E.5.1.1

Timepoint(s) of evaluation of this end point

90 days

90 giorni

E.5.2

Secondary end point(s)

Aim 1
• ICU mortality
• In-hospital mortality
• Severity and incidence of organ failures, as assessed by the SOFA score
• Incidence of AKI, as assessed by the KDIGO criteria
• Use of renal replacement therapy (RRT) during ICU stay
• Duration of the need for vasopressors during ICU stay
• Duration of mechanical ventilation during ICU stay
• Incidence of secondary-acquired infections during ICU stay
• Length of stay in ICU
• Length of stay in Hospital
Aim 2
• 90-day mortality
• Incidence of AKI, as assessed by the KDIGO criteria
• ICU mortality
• In-hospital mortality
• Severity and incidence of organ failures, as assessed by the SOFA score
• Use of renal replacement therapy (RRT) during ICU stay
• Incidence of severe metabolic acidosis
• Incidence of severe hyperkalemia
• Duration of mechanical ventilation
• Length of stay in ICU
• Length of stay in Hospital

Obiettivo 1
• Mortalità in Terapia Intensiva
• Mortalità intra-ospedaliera
• Gravità e incidenza di insufficienze d’organo, valutate con il punteggio SOFA
• Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
• Uso di tecniche di depurazione renale durante degenza in Terapia Intensiva
• Durata della necessità di farmaci vasopressori durante degenza in Terapia Intensiva
• Durata della ventilazione meccanica durante degenza in Terapia Intensiva
• Incidenza di infezioni secondarie acquisite, durante degenza in Terapia Intensiva
• Durata della degenza in Terapia Intensiva
• Durata della degenza ospedaliera
Obiettivo 2
• Mortalità a 90 giorni
• Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
• Mortalità in Terapia Intensiva
• Mortalità intra-ospedaliera
• Gravità e incidenza di insufficienze d’organo, valutate con il punteggio SOFA
• Uso di tecniche di depurazione renale durante degenza in Terapia Intensiva
• Incidenza di grave acidosi metabolica
• Incidenza d grave iperkalemia
• Durata della ventilazione meccanica durante degenza in Terapia Intensiva
• Durata della degenza in Terapia Intensiva
• Durata della degenza ospedaliera

E.5.2.1

Timepoint(s) of evaluation of this end point

90 days

90 giorni

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

Yes

E.8.2.3.1

Comparator description

• Ringer Lattato
• Ringer Acetato
• Crystalsol
• Normal Saline (Na+ 154 mEq/L, Cl– 154 mEq/L)

• Ringer Lactate
• Ringer Acetate
• Crystalsol
• Normal Saline (Na+ 154 mEq/L, Cl– 154 mEq/L)

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.8.5.1

Number of sites anticipated in the EEA

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

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

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

LVLS

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

751

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

501

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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 addmitted in septic shock may not be able to fully understand the informations to the patient and give their informed consent. In all these cases information delivery will be postponed

La maggior parte dei pazienti in shock settico non sarà in grado di comprendere le informazioni fornite e di dare il proprio consenso primo di iniziare i trattamenti in studio In questi casi le informazioni verrano fornite ai pazienti successivamente

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Patients after the end of the trial will be treated according to Clinical Guidelines.

I pazienti alla fine della sperimentazione verranno trattati secondo le linee guida cliniche.

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

2018-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-08

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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