Vasopressin and methylprednisolone for in-hospital cardiac arrest — Protocol for a randomized, double-blind, placebo-controlled trial
Year: 2021
Type: article
Study design: Study Protocol
Abstract: OBJECTIVE: To describe the clinical trial "Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest" (VAM-IHCA). METHODS: The VAM-IHCA trial is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. The study drugs consist of 40 mg methylprednisolone and 20 IU of vasopressin 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).The primary outcome is return of spontaneous circulation and key secondary outcomes include survival and survival with a favorable neurological outcome at 30 days. 492 patients will be enrolled. The trial was registered at the EU Clinical Trials Register (EudraCT Number: 2017-004773-13) on Jan. 25, 2018 and ClinicalTrials.gov (Identifier: NCT03640949) on Aug. 21, 2018. RESULTS: The trial started in October 2018 and the last patient is anticipated to be included in January 2021. The primary results will be reported after 3-months follow-up and are, therefore, anticipated in mid-2021. CONCLUSION: The current article describes the design of the VAM-IHCA trial. The results from this trial will help clarify whether the combination of vasopressin and methylprednisolone when administered during in-hospital cardiac arrest improves outcomes.
Source: Resuscitation Plus
Authors: Lars W. Andersen, Birthe Sindberg, Mathias Holmberg, Dan Isbye, Jesper Kjærgaard, Stine T. Zwisler, Søren Darling, Jacob Moesgaard Larsen, Bodil S. Rasmussen, Bo Løfgren, Kasper Glerup Lauridsen, Kim B. Pælestik, Christoffer Sølling, Anders G. Kjærgaard, Dorte Due-Rasmussen, Fredrik Folke, Mette Gitz Charlot, Kasper Iversen, Martin Schultz, Sebastian Wiberg, Rikke Malene H.G. Jepsen, Tobias Kurth, Michael Donnino, Hans Kirkegaard, Asger Granfeldt
Institutions: Aarhus University, Aarhus University Hospital, Central Denmark Region, Regionshospitalet Viborg, University of Copenhagen, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Aalborg University, Regional Hospital Randers, Regional Hospital Horsens, Gentofte Hospital, Herlev Hospital, Zealand University Hospital Køge, Charité – Universitätsmedizin Berlin, Beth Israel Deaconess Medical Center
Language: English
Subfield: Emergency Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,100
Award: G7761571866
OpenAlex ID: W3127028083