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Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest (VAM-IHCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640949
Recruitment Status : Completed
First Posted : August 21, 2018
Results First Posted : January 11, 2022
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Lars Wiuff Andersen, Aarhus University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Arrest Drug: Vasopressin, Arginine Drug: Methylprednisolone Drug: NaCl Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : January 21, 2021
Actual Study Completion Date : January 21, 2022


Arm Intervention/treatment
Experimental: Vasopressin and methylprednisolone
The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).
Drug: Vasopressin, Arginine
20 IE of vasopressin per dose for a maximum of four doses (80 IU)

Drug: Methylprednisolone
40 mg methylprednisolone once

Placebo Comparator: Placebo
The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.
Drug: NaCl
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640949


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark
Copenhagen University Hospital - Gentofte
Hellerup, Denmark
Copenhagen University Hospital - Herlev
Herlev, Denmark
Horsens Regional Hospital
Horsens, Denmark
Zealand University Hospital - Køge
Køge, Denmark
Odense University Hospital
Odense, Denmark
Randers Regional Hospital
Randers, Denmark
Viborg Regional Hospital
Viborg, Denmark
Sponsors and Collaborators
Lars Wiuff Andersen
University of Aarhus
Investigators
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Principal Investigator: Lars W Andersen, MD, MPH, PhD, DMSc Aarhus University Hospital
  Study Documents (Full-Text)

Documents provided by Lars Wiuff Andersen, Aarhus University Hospital:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Wiuff Andersen, Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03640949    
Other Study ID Numbers: 00001
2017-004773-13 ( EudraCT Number )
First Posted: August 21, 2018    Key Record Dates
Results First Posted: January 11, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law.

All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Access Criteria: Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator. Authorship of publications emerging from the shared data will follow standard authorship guidelines from the International Committee of Medical Journal Editors and might or might not include authors from the steering committee depending on the nature of their involvement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Methylprednisolone
Vasopressins
Arginine Vasopressin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents