TY - JOUR
T1 - Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial
AU - Andersen, Lars W
AU - Sindberg, Birthe
AU - Holmberg, Mathias
AU - Isbye, Dan
AU - Kjærgaard, Jesper
AU - Zwisler, Stine T
AU - Darling, Søren
AU - Larsen, Jacob Moesgaard
AU - Rasmussen, Bodil S
AU - Løfgren, Bo
AU - Glerup Lauridsen, Kasper
AU - Pælestik, Kim B
AU - Sølling, Christoffer
AU - Kjærgaard, Anders G
AU - Due-Rasmussen, Dorte
AU - Folke, Fredrik
AU - Charlot, Mette Gitz
AU - Iversen, Kasper
AU - Schultz, Martin
AU - Wiberg, Sebastian
AU - Jepsen, Rikke Malene H G
AU - Kurth, Tobias
AU - Donnino, Michael
AU - Kirkegaard, Hans
AU - Granfeldt, Asger
N1 - © 2021 Published by Elsevier B.V.
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
KW - In-hospital cardiac arrest
KW - Vasopressin
KW - Methylprednisolone
KW - Randomized trial
U2 - 10.1016/j.resplu.2021.100081
DO - 10.1016/j.resplu.2021.100081
M3 - Journal article
C2 - 34223347
SN - 2666-5204
VL - 5
JO - Resuscitation plus
JF - Resuscitation plus
M1 - 100081
ER -