VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial

Phase 3

Recruiting

• Conditions: Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial
• Interventions: Drug: Sodium chloride; Drug: Vasopressin; Methylprednisolone; Hydrocortisone

• Registration Number: NCT05139849
• Lead Sponsor: Tiohundra AB

Brief Summary

This is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. The estimated study project period runs over 3-4 years, including pilot phase. Based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. In hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current ERC guidelines are eligible for randomization in the study.

Informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. Therefore, all hospitalized men \> 18 years and women \> 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (WOCBP)) and do not resuscitate (DNR) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. Only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized.

Patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control).

Primary outcome is survival at 30 days.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-17
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20
• Primary Completion: 2027-01-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1276

Inclusion Criteria

• Hospitalized men > 18 years and hospitalized women > 50 years.

Exclusion Criteria

• Patients not capable to comprehend information to decide about participation in the study
• Women considered of childbearing potential (WOCBP) i. e. premenopausal women
• Patients with do not resuscitate (DNR) descision
• Prior enrollment and randomization in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sodium chloride	Adrenaline alone arm (control) 1. At randomization 1 ml sodium chloride 9 mg/ml (placebo) will be administered as soon as possible after adrenaline during the first five cycle of drug administration during CPR 1 ml sodium chloride 9 mg/ml (placebo) will be administered only during the first cycle of drug administration during CPR b In the ICU sodium chloride 9 mg/ml (placebo) At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the dos will be reduced daily to 67 ml and 33 ml and then discontinued. Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml for 3 days.
Intervention	Vasopressin; Methylprednisolone; Hydrocortisone	Adrenaline, vasopressin and steroids arm (intervention) 1. At randomization 1 ml of vasopressin 20 IU/ml will be administered as soon as possible after adrenaline during the five first cycles of drug administration during CPR. 1 ml metylprednisolone sodium succinate 40 mg/ml will be administered only during the first cycle of drug administration during CPR 2. In the ICU Hydrocortisone 3 mg/ml At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml (300 mg hydrocortisone/ d) for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the hydrocortisone dos will be reduced daily to 67 ml (200 mg) and 33 ml (100 mg) and then discontinued). Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml (300mg hydrocortisone/ d) for maximum 3 days to prevent retardation of infarct healing.

Primary Outcome Measures

Name	Time	Method
Survival at 30 days	Survival at 30 days	Survival at 30 days

Trial Locations

Locations (2)

Tiohundra; 🇸🇪 Norrtälje, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden