Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

Lars Wiuff Andersen501 enrolled

Overview

This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

501

Conditions

Heart Arrest

Interventions

Vasopressin, ArginineDRUG

20 IE of vasopressin per dose for a maximum of four doses (80 IU)

MethylprednisoloneDRUG

40 mg methylprednisolone once

NaClDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. In-hospital cardiac arrest 2. Age ≥ 18 years 3. Received at least one dose of adrenaline during cardiopulmonary resuscitation 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 cardiac arrest

Locations (10)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Copenhagen University Hospital - Gentofte

Hellerup, Denmark

Outcomes

Primary Outcomes

Number of Participants With Return of Spontaneous Circulation

Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes

Time frame: During the cardiac arrest, an average of 20 minutes

Secondary Outcomes

Number of Participants That Survived 30 Days

Time frame: At 30 days

Number of Participants With a Favorable Neurological Outcome at 30 Days

A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.

Time frame: At 30 days

Data from ClinicalTrials.gov

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