Administration of Vasopressin and Methylprednisolone to Improve Survival Following In-Hospital Cardiac Arrest

Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest – A Randomized, Double-Blind, Placebo-Controlled Trial - VAM-IHCA trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004773-13-DK

Enrollment

492

Registered

2018-01-25

Start date

2018-02-27

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.0 Level: PT Classification code 10007515 Term: Cardiac arrest System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: SOLU-MEDROL® Product Name: Solu-Medrol Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactResearch Center for Emergency Medic

Research Center for Emergency Medicine Department of Clinical Medicine Aarhus University

lwandersen@clin.au.dk004551781511

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026