Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest
VAM-IHCA
2 other identifiers
interventional
501
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2018
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
September 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2022
CompletedMarch 2, 2022
February 1, 2022
2.3 years
August 19, 2018
October 16, 2021
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
During the cardiac arrest, an average of 20 minutes
Secondary Outcomes (2)
Number of Participants That Survived 30 Days
At 30 days
Number of Participants With a Favorable Neurological Outcome at 30 Days
At 30 days
Other Outcomes (9)
Vasopressor-free Days
7 days
Invasive Ventilation-free Days
7 days
Sequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours
24, 48 and 72 hours
- +6 more other outcomes
Study Arms (2)
Vasopressin and methylprednisolone
EXPERIMENTALThe 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).
Placebo
PLACEBO COMPARATORThe 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.
Interventions
20 IE of vasopressin per dose for a maximum of four doses (80 IU)
Eligibility Criteria
You may qualify if:
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lars Wiuff Andersenlead
- University of Aarhuscollaborator
Study Sites (10)
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
Related Publications (2)
Andersen LW, Isbye D, Kjaergaard J, Kristensen CM, Darling S, Zwisler ST, Fisker S, Schmidt JC, Kirkegaard H, Grejs AM, Rossau JRG, Larsen JM, Rasmussen BS, Riddersholm S, Iversen K, Schultz M, Nielsen JL, Lofgren B, Lauridsen KG, Solling C, Paelestik K, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Jepsen RMHG, Wiberg S, Donnino M, Kurth T, Hoybye M, Sindberg B, Holmberg MJ, Granfeldt A. Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Oct 26;326(16):1586-1594. doi: 10.1001/jama.2021.16628.
PMID: 34587236DERIVEDAndersen LW, Sindberg B, Holmberg M, Isbye D, Kjaergaard J, Zwisler ST, Darling S, Larsen JM, Rasmussen BS, Lofgren B, Lauridsen KG, Paelestik KB, Solling C, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Iversen K, Schultz M, Wiberg S, Jepsen RMHG, Kurth T, Donnino M, Kirkegaard H, Granfeldt A. Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial. Resusc Plus. 2021 Jan 30;5:100081. doi: 10.1016/j.resplu.2021.100081. eCollection 2021 Mar.
PMID: 34223347DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lars W. Andersen
- Organization
- Aarhus University
Study Officials
- PRINCIPAL INVESTIGATOR
Lars W Andersen, MD, MPH, PhD, DMSc
Aarhus University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 19, 2018
First Posted
August 21, 2018
Study Start
September 17, 2018
Primary Completion
January 21, 2021
Study Completion
January 21, 2022
Last Updated
March 2, 2022
Results First Posted
January 11, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.