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Trial record 5 of 6 for:    vasopressin and (epinephrine or adrenaline) and cardiac arrest

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

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ClinicalTrials.gov Identifier: NCT03640949
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : April 30, 2019
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 five 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)
Estimated Enrollment : 492 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021


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. Return of spontaneous circulation [ Time Frame: During the cardiac arrest ]
    Return of spontaneous circulation will be defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes


Secondary Outcome Measures :
  1. Survival [ Time Frame: At 30 days ]
  2. Favorable neurological outcome [ 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.



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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


Contacts
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Contact: Lars W Andersen, MD, MPH, PhD, DMSc +4551781511 lwandersen@clin.au.dk
Contact: Asger Granfeldt, MD, PhD, DMSc

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Signe J Riddersholm, MD, PhD         
Principal Investigator: Signe J Riddersholm, MD, PhD         
Sub-Investigator: Bodil Rasmussen, MD, PhD         
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Asger Granfeldt, MD, PhD, DMSc         
Principal Investigator: Asger Granfeldt, MD, PhD, DMSc         
Sub-Investigator: Hans Kirkegaard, MD, PhD, DMSc         
Copenhagen University Hospital - Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Dan Isbye, MD, PhD         
Principal Investigator: Dan Isbye, MD, PhD         
Sub-Investigator: Jepser Kjærgaard, MD, PhD         
Copenhagen University Hospital - Gentofte Recruiting
Hellerup, Denmark
Contact: Fredrik Folke, MD, PhD         
Principal Investigator: Fredrik Folke, MD, PhD         
Sub-Investigator: Mette Gitz Charlot, MD, PhD         
Copenhagen University Hospital - Herlev Recruiting
Herlev, Denmark
Contact: Kasper Iversen, MD, DMSc         
Principal Investigator: Kasper Iversen, MD, DMSc         
Sub-Investigator: Martin Schultz, Md, PhD         
Horsens Regional Hospital Recruiting
Horsens, Denmark
Contact: Anders Kjærgaard, MD, PhD         
Principal Investigator: Anders Kjærgaard, MD, PhD         
Sub-Investigator: Dorte Due-Rasmussen, MD         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Søren Darling, MD         
Principal Investigator: Søren Darling, MD         
Sub-Investigator: Stine Thorhauge Zwisler, MD, PhD         
Randers Regional Hospital Recruiting
Randers, Denmark
Contact: Kasper Glerup Lauridsen, MD         
Principal Investigator: Kasper Glerup Lauridsen, MD         
Sub-Investigator: Bo Løfgren, MD, PhD         
Viborg Regional Hospital Recruiting
Viborg, Denmark
Contact: Christoffer Sølling, MD, PhD         
Principal Investigator: Christoffer Sølling, MD, PhD         
Sub-Investigator: Therese Straarup, MD         
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

Additional Information:
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Responsible Party: Lars Wiuff Andersen, Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03640949     History of Changes
Other Study ID Numbers: 00001
2017-004773-13 ( EudraCT Number )
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
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
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents