Clinical Trials Register

Summary
EudraCT Number:	2022-003846-10
Sponsor's Protocol Code Number:	MJIP1.0
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2024-10-07
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

Czechia - SUKL

A.2

EudraCT number

2022-003846-10

A.3

Full title of the trial

A pilot study comparing the haemodynamic effects and safety of an intravenous fluid bolus of 0.5M sodium lactate against 3% saline in patients with septic shock

Pilotní studie hodnotící hemodynamické účinky a bezpečnost intravenozního podání 0.5M roztoku laktátu sodného a 3% roztoku chloridu sodného u pacientů v septickém šoku

A.3.1

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

A research activity comparing the effect of two types of solutions used in the infusion fluid treatment of a serious infection associated with vital organ dysfunction and blood circulation failure.

Výzkumná činnost srovnávající vlastnosti dvou typů roztoků užívaných při infuzní tekutinové léčbě závažné infekce spojené s poruchou funkce životně důležitých orgánů a poruchou krevního oběhu.

A.3.2

Name or abbreviated title of the trial where available

SOLACE SEPSIS

A.4.1

Sponsor's protocol code number

MJIP1.0

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	Fakultní nemocnice Plzeň
B.1.3.4	Country	Czechia
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	Univerzita Karlova
B.4.2	Country	Czechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fakultní nemocnice Plzeň
B.5.2	Functional name of contact point	Centrum klinických studií
B.5.3	Address:
B.5.3.1	Street Address	Edvarda Beneše 1128/13
B.5.3.2	Town/ city	Plzeň
B.5.3.3	Post code	301 00
B.5.3.4	Country	Czechia
B.5.4	Telephone number	+420725940248

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	No
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	half-molar sodium lactate
D.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	half-molar sodium lactate
D.3.9.3	Other descriptive name	Sodium lactate
D.3.9.4	EV Substance Code	SUB15300MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mol mole(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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	Comparator
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	No
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	3% sodium chloride
D.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium chloride
D.3.9.3	Other descriptive name	Natrium chloride
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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

Septic shock fluid treatment

Tekutinová terapie septického šoku

E.1.1.1

Medical condition in easily understood language

Septic shock

Septický šok

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	26.0
E.1.2	Level	LLT
E.1.2	Classification code	10040580
E.1.2	Term	Shock septic
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

To compare the hemodynamic effects and safety of an intravenous fluid bolus of 0.5M sodium lactate (3ml/kg over 30 min) against 3% sodium chloride (3ml/kg over 30 min) in patients with septic shock

Hodnocení hemodynamického účinku a bezpečnosti intravenózního bolusu 0,5 M laktátu sodného (3 ml/kg po dobu 30 minut) s 3% chloridem sodným (3 ml/kg po dobu 30 minut) u pacientů se septickým šokem

E.2.2

Secondary objectives of the trial

To assess acid base and potential anti-inflammatory effects.

Posouzení acidobazických a potenciálně protizánětlivých účinků hypertonického roztoku laktátu sodného.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age criteria: 18 - 90 years
Septic shock - Sepsis 3 criteria
Acute change in total SOFA score ≥ 2 due to infection
Use of vasopressor drug to maintain target blood pressure
Lactate ≥ 2 mmol/L within last 24 hrs
Likely need for fluid resuscitation
Poor peripheral perfusion as evidenced by 2 out of 4:
peripheral cyanosis with delayed capillary refill ≥ 2 sec
low urine output (< 0.2ml/kg/hr for at least 2hrs)
clouded sensorium/poor mentation
positive passive leg raising test
Written informed consent from patient or two independent physicians.

Pacient hospitalizován na JIP a zároveň
věk 18 – 90 let a zároveň
v septickém šoku – kritéria Sepsis-3
náhlá změna v celkovém SOFA skóre ≥ 2 v důsledku infekce
užití vasopresorů k udržení cílového tlaku krve
laktát ≥ 2 mmol/L během posledních 24 hodin a zároveň
potřeba tekutinové resuscitace, o čemž svědčí alespoň 2 z následujících 4 známek špatné periferní perfuze:
periferní cyanóza s opožděným kapilárním návratem ≥ 2 vteřiny
nízká produkce moči  (< 0.2ml/kg/hod. po dobu alespoň 2 hod.)
alterovaný stav vědomí/porucha kognitivních funkcí
pozitivní test pasivní elevace dolních končetin
písemný informovaný souhlas pacienta nebo dvou nezávislých lékařů

E.4

Principal exclusion criteria

Poor transthoracic echo windows
Actual body weight > 160 kg
Hypernatremia: [Na] >150 mEq/L
Cardiac tamponade
Uncorrected severe valvular heart disease or life-threatening arrhythmia
Moribund patients likely to die before the study protocol is completed
Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L
Pregnancy

pacienti se špatným anatomickým přístupem limitujícím TTE vyšetření
aktuální tělesná hmotnost >160 kg
hypernatrémie: [Na] >150 mmol/L
tamponáda srdeční
nenapravitelné závažné chlopenní srdeční vady nebo život ohrožující arytmie
umírající pacienti, kteří pravděpodobně zemřou před dokončením protokolu studie
pacient s absolutní indikací pro okamžitou akutní hemodialýzu/hemofiltraci (během 2 hod.) při pH < 7.0, K > 7.0mmol/L
život ohrožující krvácení
známé těhotenství
informovaný souhlas nelze získat

E.5 End points

E.5.1

Primary end point(s)

Change in cardiac stroke work (SW = SV x MAP) assessed by means of transthoracic echocardiography (SV) and a fluid filled arterial pressure transducer system (MAP).

Dynamika změn hodnot tepové práce srdce (SW = SV x MAP) hodnocená pomocí transtorakální echokardiografie (SV) a arteriálního katetru (MAP).

E.5.1.1

Timepoint(s) of evaluation of this end point

Measured at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus (0.5M NaLact or 3% NaCl).

Měřeno v době zahájení infuze, po 30 minutách a po 60 minutách od zahájení příslušného bolusu (0,5M NaLact nebo 3% NaCl).

E.5.2

Secondary end point(s)

To assess the effects on hemodynamics, arterial blood gas, cardiac function assessment by echocardiography, vasopressor requirement, shock reversal, renal and liver function, urine output, ICU and 30-day mortality.

Posouzení účinků na hemodynamiku, arteriální krevní plyny, hodnocení srdeční funkce pomocí echokardiografie, potřeba vazopresorů, vymizení šoku, renální a jaterní funkce, výdej moči a mortalita na JIP a během 30 dní.

E.5.2.1

Timepoint(s) of evaluation of this end point

Measured at time of start of infusion, at 30 minutes and at 60 minutes from the start of the fluid bolus (0.5M NaLact or 3% NaCl).

Měřeno před zahájením infuze, v době zahájení infuze, po 30 minutách a po 60 minutách od zahájení příslušného bolusu (0,5M NaLact nebo 3% NaCl).

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

Poslední návštěva posledního pacienta

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

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:

154

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 2024-10-07.

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

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Loss of consciousness due to severe systemic infection or septic shock.

Porucha vědomí z důvodu závažné systémové infekce respektive septického šoku.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

154

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)

None

Žádné

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

2023-11-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2024-05-02

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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