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NCT Number: NCT03640949

Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

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.

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Key information

Conditions

Heart Arrest Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In-hospital cardiac arrest
  • Age ≥ 18 years
  • Received at least one dose of adrenaline during cardiopulmonary resuscitation

Exclusion criteria

  • Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
  • Prior enrollment in the trial
  • Invasive mechanical circulatory support at the time of the cardiac arrest
  • Known or suspected pregnancy at the time of the cardiac arrest

Treatment and study plan

Vasopressin, Arginine

Drug

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

methylprednisolone

Drug

40 mg methylprednisolone once

NaCl

Drug

Placebo

Primary outcomes

  1. Number of Participants With Return of Spontaneous Circulation

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

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

Secondary outcomes

  1. Number of Participants That Survived 30 Days

    Time frame: At 30 days

  2. Number of Participants With a Favorable Neurological Outcome at 30 Days

    Time frame: 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.

Other outcomes

  1. Vasopressor-free Days

    Time frame: 7 days

    Vasopressor-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving vasopressors and is alive.

  2. Invasive Ventilation-free Days

    Time frame: 7 days

    Invasive ventilation-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving invasive ventilation and is alive.

  3. Sequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours

    Time frame: 24, 48 and 72 hours

    The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score.

  4. Hospital Disposition

    Time frame: At hospital discharge, up to 1 year

    Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.

  5. Survival

    Time frame: At 90 days, 180 days, and 1 year

  6. Favorable Neurological Outcome

    Time frame: At 90 days, 180 days, and 1 year

    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.

  7. Modified Rankin Scale (mRS)

    Time frame: At 30 days, 90 days, 180 days, and 1 year

    The mRS is a 7-point scale, ranging from 0 (no symptoms) to 6 (dead), assessing the degree of disability and dependence after a neurological injury such as stroke or cardiac arrest. A good outcome will be defined as a mRS of 0 to 3 and a poor outcome as 4 to 6.

  8. Glasgow Outcome Scale Extended (GOSE)

    Time frame: At 30 days, 90 days, 180 days, and 1 year

    The GOSE is a 8-point scale that is an extension of the Glasgow Outcomes Scale (which is identical to the CPC, only with inverse scores) where the scores 1, 2 and 3 from the CPC score is divided into two.

  9. Health-related Quality of Life (EQ-5D-5L)

    Time frame: At 30 days, 90 days, 180 days, and 1 year

    The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1).

Sponsors and collaborators

Lead sponsor

Lars Wiuff Andersen

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

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

Acronym: VAM-IHCA

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 21, 2018
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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