Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial

Lars W Andersen; Birthe Sindberg; Mathias Johan Holmberg; Dan Lou Isbye; Jesper Kjaergaard; Stine Thorhauge Zwisler; Søren  Darling; Jacob Moesgaard Larsen; Bodil Steen Rasmussen; Bo Løfgren; Kasper Glerup Lauridsen; Kim Bolther Pælestik; Christoffer Sølling; Anders Gade Kjærgaard; Dorte Due-Rasmussen; Fredrik Folke; Mette Gitz Charlot; Kasper Iversen; Martin Schultz; Sebastian Wiberg; Rikke M H G Jepsen; Tobias Kurth; MIchael Donnino; Hans Kirkegaard; Asger Granfeldt

doi:10.1016/j.resplu.2021.100081

Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial

Lars W Andersen^*, Birthe Sindberg, Mathias Johan Holmberg, Dan Lou Isbye, Jesper Kjaergaard, Stine Thorhauge Zwisler, Søren Darling, Jacob Moesgaard Larsen, Bodil Steen Rasmussen, Bo Løfgren, Kasper Glerup Lauridsen, Kim Bolther Pælestik, Christoffer Sølling, Anders Gade Kjærgaard, Dorte Due-Rasmussen, Fredrik Folke, Mette Gitz Charlot, Kasper Iversen, Martin Schultz, Sebastian WibergRikke M H G Jepsen, Tobias Kurth, MIchael Donnino, Hans Kirkegaard, Asger Granfeldt

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

6 Citations (Scopus)

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.

Original language	Danish
Article number	100081
Journal	Resuscitation Plus
Volume	5
ISSN	2666-5204
DOIs	https://doi.org/10.1016/j.resplu.2021.100081
Publication status	Published - Mar 2021

Keywords

In-hospital cardiac arrest
Methylprednisolone
Randomized trial
Vasopressin

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Andersen, L. W., Sindberg, B., Holmberg, M. J., Isbye, D. L., Kjaergaard, J., Zwisler, S. T., Darling, S., Larsen, J. M., Rasmussen, B. S., Løfgren, B., Glerup Lauridsen, K., Pælestik, K. B., Sølling, C., Kjærgaard, A. G., Due-Rasmussen, D., Folke, F., Charlot, M. G., Iversen, K., Schultz, M., ... Granfeldt, A. (2021). Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial. Resuscitation Plus, 5, Article 100081. https://doi.org/10.1016/j.resplu.2021.100081

@article{eb1573907fd544a5bdc37692f3f9c74b,

title = "Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial",

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.",

keywords = "In-hospital cardiac arrest, Methylprednisolone, Randomized trial, Vasopressin",

author = "Andersen, {Lars W} and Birthe Sindberg and Holmberg, {Mathias Johan} and Isbye, {Dan Lou} and Jesper Kjaergaard and Zwisler, {Stine Thorhauge} and S{\o}ren Darling and Larsen, {Jacob Moesgaard} and Rasmussen, {Bodil Steen} and Bo L{\o}fgren and {Glerup Lauridsen}, Kasper and P{\ae}lestik, {Kim Bolther} and Christoffer S{\o}lling and Kj{\ae}rgaard, {Anders Gade} and Dorte Due-Rasmussen and Fredrik Folke and Charlot, {Mette Gitz} and Kasper Iversen and Martin Schultz and Sebastian Wiberg and Jepsen, {Rikke M H G} and Tobias Kurth and MIchael Donnino and Hans Kirkegaard and Asger Granfeldt",

year = "2021",

month = mar,

doi = "10.1016/j.resplu.2021.100081",

language = "Dansk",

volume = "5",

journal = "Resuscitation Plus",

issn = "2666-5204",

publisher = "Elsevier B.V.",

}

Andersen, LW , Sindberg, B , Holmberg, MJ, Isbye, DL, Kjaergaard, J, Zwisler, ST, Darling, S, Larsen, JM, Rasmussen, BS, Løfgren, B , Glerup Lauridsen, K, Pælestik, KB, Sølling, C , Kjærgaard, AG, Due-Rasmussen, D, Folke, F, Charlot, MG, Iversen, K, Schultz, M, Wiberg, S, Jepsen, RMHG, Kurth, T, Donnino, MI, Kirkegaard, H & Granfeldt, A 2021, 'Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial', Resuscitation Plus, vol. 5, 100081. https://doi.org/10.1016/j.resplu.2021.100081

Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial. / Andersen, Lars W ; Sindberg, Birthe ; Holmberg, Mathias Johan et al.
In: Resuscitation Plus, Vol. 5, 100081, 03.2021.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Vasopressin and methylprednisolone for in-hospital cardiac arrest

T2 - Protocol for a randomized, double-blind, placebo-controlled trial

AU - Andersen, Lars W

AU - Sindberg, Birthe

AU - Holmberg, Mathias Johan

AU - Isbye, Dan Lou

AU - Kjaergaard, Jesper

AU - Zwisler, Stine Thorhauge

AU - Darling, Søren

AU - Larsen, Jacob Moesgaard

AU - Rasmussen, Bodil Steen

AU - Løfgren, Bo

AU - Glerup Lauridsen, Kasper

AU - Pælestik, Kim Bolther

AU - Sølling, Christoffer

AU - Kjærgaard, Anders Gade

AU - Due-Rasmussen, Dorte

AU - Folke, Fredrik

AU - Charlot, Mette Gitz

AU - Iversen, Kasper

AU - Schultz, Martin

AU - Wiberg, Sebastian

AU - Jepsen, Rikke M H G

AU - Kurth, Tobias

AU - Donnino, MIchael

AU - Kirkegaard, Hans

AU - Granfeldt, Asger

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 - Methylprednisolone

KW - Randomized trial

KW - Vasopressin

UR - http://www.scopus.com/inward/record.url?scp=85122530256&partnerID=8YFLogxK

U2 - 10.1016/j.resplu.2021.100081

DO - 10.1016/j.resplu.2021.100081

M3 - Tidsskriftartikel

C2 - 34223347

SN - 2666-5204

VL - 5

JO - Resuscitation Plus

JF - Resuscitation Plus

M1 - 100081

ER -

Vasopressin and methylprednisolone for in-hospital cardiac arrest: Protocol for a randomized, double-blind, placebo-controlled trial

Abstract

Keywords

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