VAsopressin and STeroids in addition to Adrenaline in cardiac arrest

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2019
INTERVENTION: Trade Name: Empressin Product Name: Empressin Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use Trade Name: Solu‐medrol Pharmaceutical Form: Powder and solvent for emulsion for injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use Trade Name: Solu‐Cortef Pharmaceutical Form: Powder and solvent for emulsion for injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use Trade Name: Adrenalin Product Name: Adrenaline Pharmaceutical Form: Injection CONDITION: In hospital cardiac arrest Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: ; Main Objective: The primary objective of the study is to determine whether the use of a combination of adrenaline, vasopressin and steroids will increase 30 days survival in cardiac arrest patients compared to standard adrenaline alone.; ; ; Secondary Objective: Neurological outcome at 30 days (mRS and GOS‐E); ROSC; Survival at 6 months; Neurological outcome (mRS and GOS‐E) at 6 months; Arterial pressure during and approximately 20 minutes after CPR; Arterial pressure and central venous oxygen saturation (ScvO2) during days 1 through 10 after randomization; Number of organ failure–free days during days 1 to discharge ; Hemodynamics according to local practice; Organ failure SOFA/SAPS; Compliance to protocol for drug administration; Transfusion requiring gastrointestinal bleeding; Iv antibiotic or antimycotic requiring infection; Insulin requiring hyperglycemia treatment in previous non diabetic patient; Primary end point(s): Survival at 30 days Timepoint(s) of evaluation of this end point: 30 Days after cardiac arrest SECONDARY OUTCOME: ; Secondary end point(s): Neurological outcome at 30 days (mRS and GOS‐E) ; ROSC ; Survival at 6 months ; Neurological outcome (mRS and GOS‐E) at 6 months ; Arterial pressure during and approximately 20 minutes after CPR ; Arterial pressure and central venous oxygen saturation (ScvO2) during days 1 through 10 after randomization ; Number of organ failure–free days during days 1 to discharge ; Hemodynamics ; Organ failure SOFA/SAPS ; Timepoint(s) of evaluation of this end point: please see E.5.2 INCLUSION CRITERIA: In hospital cardiac arrest patients meeting criteria for adrenaline administration according to current ERC guidelines are eligible for the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Epistemonikos ID: 8e6713d3b5c7e5f61d784e1b1945ab1510a2f82a
First added on: Jul 27, 2021