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Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock (LevoHeartShock)

Primary Purpose

Cardiogenic Shock

Status

Not yet recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Levosimendan 2.5 MG/ML Injectable Solution

Placebo

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring heart failure, levosimendan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patient with cardiogenic shock defined by:

Adequate intravascular volume
Norepinephrine infusion <1 microgram/kg/min to maintain MAP at least at 65 mmHg for at least 3 hours and less than 12h or dobutamine ≥ 5 microgram/kg/min since at least 3h and less than 12h
Tissue hypoperfusion: at least 2 signs (lactate ≥ 2 mmol/l, mottling, oliguria, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg)
Clinical pulmonary congestion or elevated natriuretic peptides or echocardiographic sign of elevated left ventricular pressure or elevated right atrial pressure.

Exclusion Criteria:

Myocardial sideration after cardiac arrest of non-cardiac etiology
Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support
Extra Corporel Life Support (Extracorporeal Membrane Oxygenation (ECMO) or Impella)
Chronic renal failure requiring hemodialysis
Cardiotoxic poisoning
Septic cardiomyopathy
Previous levosimendan administration within 15 days
Cardiac arrest resuscitation >30 minutes
Cerebral deficit with fixed dilated pupils
Patient moribund on the day of randomization
Irreversible neurological pathology
Known hypersensitivity to levosimendan or placebo, or one of its excipients
Woman of childbearing age without effective contraception
Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty for judicial or administrative decision
- Person under psychiatric care
- Minor person (non-emancipated)
- Adult person under legal protection (any form of public guardianship)

Sites / Locations

CHRU Strasbourg -Nouvel Hôpital Civil
AP-HM, la Timone Hospital, Marseille
AP-HM, Nord Hospital, Marseille
CHU Caen
CHU Dijon, BOCAGE Hospital
CHU Besançon Jean Minjoz Hospital
CHU Nîmes, Carémeau Hospital
CHU Bordeaux - Hopital haut-leveque
CHU de Toulouse
CHU Limoges, Dupuytren Hospital
CHU Montpellier, Arnaud de Villeneuve Hospital
CHU Montpellier, site Lapeyronie
CHU Rennes, Pontchaillou Hospital
CHU Grenoble, Michallon Hospital
CHU Nantes - Hôtel Dieu
CHR Metz-Thionville, Mercy Hospital
CHRU Lille, Cœur Poumon Institute
APHP, Raymond Poincaré Hospital
CHRU Clermont- Ferrand Gabriel-Montpied
Hospices Civils de Lyon - Louis Pradel Hospital
CHU Rouen, Charles Nicolle Hospital
APHP, Henri Mondor Hospital
CH Henri Duffaut, Avignon
APHP -Lariboisière Hospital (Cardiology department)
APHP, Lariboisière Hospital (intensive care unit and toxicology)
APHP, La Pitié Salpêtrière (medical intensive care unit)
APHP- HEGP Paris
CHRU Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levosimendan

Placebo

Arm Description

Experimental group: patients with cardiogenic shock treated with levosimendan in addition to the conventional strategy.

Control group: Patients with cardiogenic shock treated with placebo for levosimendan in addition to the conventional strategy.

Outcomes

Primary Outcome Measures

Proportion of All-cause mortality

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Proportion of Extra Corporel Life Support implantation

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Proportion of Dialysis

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Secondary Outcome Measures

Proportion of All-cause mortality

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Proportion of Extra Corporel Life Support implantation

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Proportion of dialysis

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Proportion of death

Composite endpoint of major adverse cardiovascular events defined as death, cardiac transplantation, escalation to permanent left ventricular assist device, stroke, recurrent myocardial infarction, urgent coronary revascularization, dialysis, re-hospitalization for heart failure

Proportion of cardiac transplantation

Proportion of escalation to permanent Left Ventricular Assist Device

Proportion of stroke

Proportion of recurrent myocardial infarction

Proportion of urgent coronary revascularization

Proportion of dialysis

Proportion of re-hospitalization for heart failure

Amount of administered dobutamine

Duration of administered dobutamine

Duration with abnormal lactate value

Lactate Clearance

Number of days with organ failure(s)

Defined with the SOFA score

The number of days between inclusion and D30, without organ failure

Defined with the SOFA score

Duration of catecholamine hemodynamic support

The number of days between inclusion and D30 without hemodynamic support

Duration of mechanical ventilation

The number of days alive without mechanical ventilation

Duration of intensive care unit stay

Duration of hospitalization

Occurrence of arrhythmias

Including atrial fibrillation and other arrhythmias, ventricular tachycardia, ventricular fibrillation, torsade de pointe

Full Information

NCT ID

NCT04020263

First Posted

June 28, 2019

Last Updated

July 16, 2019

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT04020263

Brief Title

Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

Acronym

LevoHeartShock

Official Title

Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiogenic Shock

Keywords

heart failure, levosimendan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The LevoHeartShock trial is a prospective, double-blind, multicenter, randomized controlled trial comparing the early initiation of levosimendan versus placebo in patients with cardiogenic shock treated with vasopressor therapy according to a conventional strategy of inotrope use (dobutamine as first line agent).

Masking

ParticipantCare ProviderInvestigator

Masking Description

The study will be double-blinded. Investigator masking to group assignment after randomization will be guaranteed by use of a placebo. The packaging and labeling of placebo and levosimendan vials will be similar to guarantee the double blinded aspect.

Allocation

Randomized

Enrollment

610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Levosimendan

Arm Type

Experimental

Arm Description

Experimental group: patients with cardiogenic shock treated with levosimendan in addition to the conventional strategy.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Control group: Patients with cardiogenic shock treated with placebo for levosimendan in addition to the conventional strategy.

Intervention Type

Drug

Intervention Name(s)

Levosimendan 2.5 MG/ML Injectable Solution

Intervention Description

Levosimendan will be diluted with Glucose G5%. The reconstitution of levosimendan will be performed, as close as possible to the start of the infusion. A continuous infusion of levosimendan will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be diluted with Glucose G5%. The reconstitution of Placebo will be performed, as close as possible to the start of the infusion. A continuous infusion of Placebo will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.

Primary Outcome Measure Information:

Title

Proportion of All-cause mortality

Description

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Time Frame

Day 30 following randomization

Title

Proportion of Extra Corporel Life Support implantation

Description

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Time Frame

Day 30 following randomization

Title

Proportion of Dialysis

Description

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Time Frame

Day 30 following randomization

Secondary Outcome Measure Information:

Title

Proportion of All-cause mortality

Description

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Time Frame

Days 7, 30, 60, 90, 180

Title

Proportion of Extra Corporel Life Support implantation

Description

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Time Frame

Days 7, 30, 60, 90, 180

Title

Proportion of dialysis

Description

Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)

Time Frame

Days 7, 30, 60, 90, 180

Title

Proportion of death

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of cardiac transplantation

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of escalation to permanent Left Ventricular Assist Device

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of stroke

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of recurrent myocardial infarction

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of urgent coronary revascularization

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of dialysis

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Proportion of re-hospitalization for heart failure

Description

Time Frame

Days 30, 60, 90, 180 and 12 months

Title

Amount of administered dobutamine

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

Title

Duration of administered dobutamine

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

Title

Duration with abnormal lactate value

Description

Lactate Clearance

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

Title

Number of days with organ failure(s)

Description

Defined with the SOFA score

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

Title

The number of days between inclusion and D30, without organ failure

Description

Defined with the SOFA score

Time Frame

From baseline to day 30

Title

Duration of catecholamine hemodynamic support

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

Title

The number of days between inclusion and D30 without hemodynamic support

Time Frame

From baseline to day 30

Title

Duration of mechanical ventilation

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

Title

The number of days alive without mechanical ventilation

Time Frame

From baseline to day 30

Title

Duration of intensive care unit stay

Time Frame

Up to Intensive Care Unit discharge (assessed up to 1 month)

Title

Duration of hospitalization

Time Frame

Up to hospitalization discharge (assessed up to 1 month)

Title

Occurrence of arrhythmias

Description

Including atrial fibrillation and other arrhythmias, ventricular tachycardia, ventricular fibrillation, torsade de pointe

Time Frame

From baseline to Intensive Care Unit discharge (assessed up to 1 month)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patient with cardiogenic shock defined by: Adequate intravascular volume Norepinephrine infusion <1 microgram/kg/min to maintain MAP at least at 65 mmHg for at least 3 hours and less than 12h or dobutamine ≥ 5 microgram/kg/min since at least 3h and less than 12h Tissue hypoperfusion: at least 2 signs (lactate ≥ 2 mmol/l, mottling, oliguria, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg) Clinical pulmonary congestion or elevated natriuretic peptides or echocardiographic sign of elevated left ventricular pressure or elevated right atrial pressure. Exclusion Criteria: Myocardial sideration after cardiac arrest of non-cardiac etiology Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support Extra Corporel Life Support (Extracorporeal Membrane Oxygenation (ECMO) or Impella) Chronic renal failure requiring hemodialysis Cardiotoxic poisoning Septic cardiomyopathy Previous levosimendan administration within 15 days Cardiac arrest resuscitation >30 minutes Cerebral deficit with fixed dilated pupils Patient moribund on the day of randomization Irreversible neurological pathology Known hypersensitivity to levosimendan or placebo, or one of its excipients Woman of childbearing age without effective contraception Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code: Pregnant, parturient or breastfeeding woman Person deprived of liberty for judicial or administrative decision Person under psychiatric care Minor person (non-emancipated) Adult person under legal protection (any form of public guardianship)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bruno LEVY, Pr

Phone

+33 3 83 15 40 84

b.levy@chru-nancy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clément DELMAS, Dr

Organizational Affiliation

CHU Toulouse

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Nicolas GIRERD, Pr

Organizational Affiliation

CHRU Nancy

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Patrick ROSSIGNOL, Pr

Organizational Affiliation

CHRU Nancy

Official's Role

Study Chair

Facility Information:

Facility Name

CHRU Strasbourg -Nouvel Hôpital Civil

City

Strasbourg

State/Province

Bas-Rhin

ZIP/Postal Code

67091

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ferhat Meziani, MD

First Name & Middle Initial & Last Name & Degree

Ferhat Meziani, MD

Facility Name

AP-HM, la Timone Hospital, Marseille

City

Marseille

State/Province

Bouches Du Rhône

ZIP/Postal Code

13005

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Gainnier, MD

First Name & Middle Initial & Last Name & Degree

Marc Gainnier, MD

Facility Name

AP-HM, Nord Hospital, Marseille

City

Marseille

State/Province

Bouches Du Rhône

ZIP/Postal Code

13015

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent Bonello, MD

First Name & Middle Initial & Last Name & Degree

Laurent Bonello, MD

Facility Name

CHU Caen

City

Caen

State/Province

Calvados

ZIP/Postal Code

14000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katrien Blanchart, MD

First Name & Middle Initial & Last Name & Degree

Katrien Blanchart, MD

Facility Name

CHU Dijon, BOCAGE Hospital

City

Dijon

State/Province

Côte d'Or

ZIP/Postal Code

21000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Pierre Quenot, MD

First Name & Middle Initial & Last Name & Degree

Jean-Pierre Quenot, MD

Facility Name

CHU Besançon Jean Minjoz Hospital

City

Besançon

State/Province

Doubs

ZIP/Postal Code

25000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilles Capellier, MD

First Name & Middle Initial & Last Name & Degree

Gilles Capellier, MD

Facility Name

CHU Nîmes, Carémeau Hospital

City

Nîmes

State/Province

Gard

ZIP/Postal Code

30029

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoît Lattuca, MD

First Name & Middle Initial & Last Name & Degree

Benoît Lattuca, MD

Facility Name

CHU Bordeaux - Hopital haut-leveque

City

Bordeaux

State/Province

Gironde

ZIP/Postal Code

33600

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edouard Gerbaud, MD

First Name & Middle Initial & Last Name & Degree

Edouard Gerbaud, MD

Facility Name

CHU de Toulouse

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31059

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clément Delmas, MD

First Name & Middle Initial & Last Name & Degree

Clément Delmas, MD

Facility Name

CHU Limoges, Dupuytren Hospital

City

Limoges

State/Province

Haute-Vienne

ZIP/Postal Code

87000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Vignon, MD

First Name & Middle Initial & Last Name & Degree

Philippe Vignon, MD

Facility Name

CHU Montpellier, Arnaud de Villeneuve Hospital

City

Montpellier

State/Province

Hérault

ZIP/Postal Code

34090

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

François Roubille, MD

First Name & Middle Initial & Last Name & Degree

François Roubille, MD

Facility Name

CHU Montpellier, site Lapeyronie

City

Montpellier

State/Province

Hérault

ZIP/Postal Code

34090

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kada Klouche, MD

First Name & Middle Initial & Last Name & Degree

Kada Klouche, MD

Facility Name

CHU Rennes, Pontchaillou Hospital

City

Rennes

State/Province

Ille Et Vilaine

ZIP/Postal Code

35000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume Leurent, MD

First Name & Middle Initial & Last Name & Degree

Guillaume Leurent, MD

Facility Name

CHU Grenoble, Michallon Hospital

City

La Tronche

State/Province

Isère

ZIP/Postal Code

38043

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Terzi, MD

First Name & Middle Initial & Last Name & Degree

Nicolas Terzi, MD

Facility Name

CHU Nantes - Hôtel Dieu

City

Nantes

State/Province

Loire-Atlantique

ZIP/Postal Code

44000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Reignier, MD

First Name & Middle Initial & Last Name & Degree

Jean Reignier, MD

Facility Name

CHR Metz-Thionville, Mercy Hospital

City

Ars-Laquenexy

State/Province

Moselle

ZIP/Postal Code

57245

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume Louis, MD

First Name & Middle Initial & Last Name & Degree

Guillaume Louise, MD

Facility Name

CHRU Lille, Cœur Poumon Institute

City

Lille

State/Province

Nord

ZIP/Postal Code

59000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Lamblin, MD

First Name & Middle Initial & Last Name & Degree

Nicolas Lamblin, MD

Facility Name

APHP, Raymond Poincaré Hospital

City

Garches

State/Province

Paris

ZIP/Postal Code

92380

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Djillali Annane, MD

First Name & Middle Initial & Last Name & Degree

Djillali Annane, MD

Facility Name

CHRU Clermont- Ferrand Gabriel-Montpied

City

Clermont- Ferrand

State/Province

Puy-de-Dôme

ZIP/Postal Code

63000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elisabeth Coupez, MD

First Name & Middle Initial & Last Name & Degree

Elisabeth Coupez, MD

Facility Name

Hospices Civils de Lyon - Louis Pradel Hospital

City

Bron

State/Province

Rhône

ZIP/Postal Code

69500

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Bonnefoy, MD

First Name & Middle Initial & Last Name & Degree

Eric Bonnefoy, MD

Facility Name

CHU Rouen, Charles Nicolle Hospital

City

Rouen

State/Province

Seine Maritime

ZIP/Postal Code

76000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabienne Tamion, MD

First Name & Middle Initial & Last Name & Degree

Emmanuel Besnier, MD

First Name & Middle Initial & Last Name & Degree

Fabienne Tamion, MD

Facility Name

APHP, Henri Mondor Hospital

City

Créteil

State/Province

Val De Marne

ZIP/Postal Code

94010

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Lim, MD

First Name & Middle Initial & Last Name & Degree

Pascal LIM, MD

Facility Name

CH Henri Duffaut, Avignon

City

Avignon

State/Province

Vaucluse

ZIP/Postal Code

84000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphane Andrieu, MD

First Name & Middle Initial & Last Name & Degree

Stéphane Andrieu, MD

Facility Name

APHP -Lariboisière Hospital (Cardiology department)

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephane Menzo-Silberman

First Name & Middle Initial & Last Name & Degree

Stephane Menzo-Silberman, MD

Facility Name

APHP, Lariboisière Hospital (intensive care unit and toxicology)

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno Megarbane, MD

First Name & Middle Initial & Last Name & Degree

Bruno Megarbane, MD

Facility Name

APHP, La Pitié Salpêtrière (medical intensive care unit)

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain Combes, MD

First Name & Middle Initial & Last Name & Degree

Alain Combes, MD

Facility Name

APHP- HEGP Paris

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadia Aissaoui Balanant, MD

First Name & Middle Initial & Last Name & Degree

Nadia Aissaoui Balanant, MD

Facility Name

CHRU Nancy

City

Vandoeuvre les Nancy

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno Lévy, Prof

First Name & Middle Initial & Last Name & Degree

Bruno LEVY, Prof

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

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