Administration of Vasopressin and Methylprednisolone to Improve Survival Following In-Hospital Cardiac Arrest
Phase 1
- Conditions
- The study will include patients with in-hospital cardiac arrest (IHCA). The study will test whether treatment with methylprednisolone and vasopressin added to standard care will improve survival following IHCA. The study is a multicenter, double-blind, placebo-controlled trial.MedDRA version: 20.0Level: PTClassification code 10007515Term: Cardiac arrestSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004773-13-DK
- Lead Sponsor
- Research Center for Emergency Medicine Department of Clinical Medicine Aarhus University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 501
Inclusion Criteria
1) In-hosptial cardiac arrest
2) Age = 18 years
3) Received at least one dose of adrenaline during CPR
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 322
Exclusion Criteria
1) Clearly documented do-not-resuscitate” order prior to the cardiac arrest
2) Prior enrollment in the trial
3) Invasive mechanical circulatory support at the time of the cardiac arrest
4) Known or suspected pregnancy at the time of the In-hosptial cardiac arrest
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to determine whether the combination of vasopressin and methylprednisolone, as compared to placebo, when administered during IHCA, will increase return of spontaneous circulation. ;Secondary Objective: To determine whether the combination of vasopressin and methylprednisolone, as compared to placebo, administered during IHCA will increase survival at 30 days and survival at 30 days with a favorable neurological outcome (cerebral performance category score 1 or 2) ;Primary end point(s): The primary outcome will be ROSC. ROSC will be defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes. ;Timepoint(s) of evaluation of this end point: The endpoint is evaluated during ongoing cardiopulmonary resuscitation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The key secondary outcomes will be survival at 30 days and survival at 30 days with a favorable neurological outcome. A favorable neurological outcome will be defined as a CPC score of 1 or 2. ;Timepoint(s) of evaluation of this end point: 30 days after the cardiac arrest