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

Andersen, Lars W.; Sindberg, Birthe; Holmberg, Mathias J.; Isbye, Dan Lou; Kjærgaard, Jesper; Zwisler, Stine Thorhauge; Darling, Søren; Larsen, J. M.; Rasmussen, Bodil Steen; Løfgren, Bo; Lauridsen, Kasper Glerup; Pælestik, Kim; Sølling, Christoffer; Kjærgaard, Anders G.; Due-Rasmussen, Dorte; Folke, Fredrik; Charlot, Mette; Iversen, Kasper; Wiberg, Sebastian; Jepsen, Rikke Malene Hartvigsen Grønholm; Kurth, Tobias; Donnino, Michael W.; Kirkegaard, Hans; Granfeldt, Asger

doi:10.1016/j.resplu.2021.100081

Cited by 9 publications

(9 citation statements)

References 49 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This trial was an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. 10 The protocol, which is provided in Supplement 1, was written by the steering committee and approved by the regional ethics committee and the Danish Medicines Agency. Minor differences between the article and the protocol are described in eAppendix 1 in Supplement 2.…”

Section: Trial Design and Oversightmentioning

confidence: 99%

Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest

Andersen

Isbye

Kjærgaard

et al. 2021

JAMA

View full text Add to dashboard Cite

IMPORTANCE Previous trials have suggested that vasopressin and methylprednisolone administered during in-hospital cardiac arrest might improve outcomes.OBJECTIVE To determine whether the combination of vasopressin and methylprednisolone administered during in-hospital cardiac arrest improves return of spontaneous circulation. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-blind, placebo-controlled trial conducted at 10 hospitals in Denmark. A total of 512 adult patients with in-hospital cardiac arrest were included between October 15, 2018, and January 21, 2021. The last 90-day follow-up was on April 21, 2021.INTERVENTION Patients were randomized to receive a combination of vasopressin and methylprednisolone (n = 245) or placebo (n = 267). The first dose of vasopressin (20 IU) and methylprednisolone (40 mg), or corresponding placebo, was administered after the first dose of epinephrine. Additional doses of vasopressin or corresponding placebo were administered after each additional dose of epinephrine for a maximum of 4 doses. MAIN OUTCOMES AND MEASURESThe primary outcome was return of spontaneous circulation. Secondary outcomes included survival and favorable neurologic outcome at 30 days (Cerebral Performance Category score of 1 or 2). RESULTS Among 512 patients who were randomized, 501 met all inclusion and no exclusion criteria and were included in the analysis (mean [SD] age, 71 [13] years; 322 men [64%]). One hundred of 237 patients (42%) in the vasopressin and methylprednisolone group and 86 of 264 patients (33%) in the placebo group achieved return of spontaneous circulation (risk ratio, 1.30 [95% CI, 1.03-1.63]; risk difference, 9.6% [95% CI, 1.1%-18.0%]; P = .03). At 30 days, 23 patients (9.7%) in the intervention group and 31 patients (12%) in the placebo group were alive (risk ratio, 0.83 [95% CI, 0.50-1.37]; risk difference: −2.0% [95% CI, −7.5% to 3.5%]; P = .48). A favorable neurologic outcome was observed in 18 patients (7.6%) in the intervention group and 20 patients (7.6%) in the placebo group at 30 days (risk ratio, 1.00 [95% CI, 0.55-1.83]; risk difference, 0.0% [95% CI, −4.7% to 4.9%]; P > .99). In patients with return of spontaneous circulation, hyperglycemia occurred in 77 (77%) in the intervention group and 63 (73%) in the placebo group. Hypernatremia occurred in 28 (28%) and 27 (31%), in the intervention and placebo groups, respectively.CONCLUSIONS AND RELEVANCE Among patients with in-hospital cardiac arrest, administration of vasopressin and methylprednisolone, compared with placebo, significantly increased the likelihood of return of spontaneous circulation. However, there is uncertainty whether this treatment results in benefit or harm for long-term survival.

show abstract

Section: Trial Design and Oversightmentioning

confidence: 99%

Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest

Andersen

Isbye

Kjærgaard

et al. 2021

JAMA

View full text Add to dashboard Cite

show abstract

“…The trial protocol and primary results have previously been published. 4,5 The VAM-IHCA trial was an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. The trial was approved by the regional ethics committee and the Danish Medicines Agency.…”

Section: Trial Design and Oversightmentioning

confidence: 99%

“…To confirm these promising findings, the Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest (VAM-IHCA) trial was conducted. 4,5 The primary short-term outcomes were recently published demonstrating a significant increase in return of spontaneous circulation with the intervention with no difference in survival or survival with a favorable outcome at 30 and 90 days. 5 A recent systematic review and meta-analysis of individual participant data also demonstrated an increase in return of spontaneous circulation while the results for survival or survival with a favorable outcome were more uncertain.…”

Section: Introductionmentioning

confidence: 99%

Effect of vasopressin and methylprednisolone vs. placebo on long-term outcomes in patients with in-hospital cardiac arrest a randomized clinical trial

et al. 2022

Self Cite

View full text Add to dashboard Cite

“…The journals most downloaded articles include a randomised controlled manikin trial evaluating suction-based airway devices, 2 a study of the impact of COVID-19 on out of hospital cardiac arrest in London, 3 a dictionary for terms used to describe drowning and aquatic injuries, 4 reviews relating to educational theories underpinning advanced life support courses 5 and extracorporeal oxygenation, 6 and the clinical trial protocol for a trial of vasopressin and methylprednisolone during in-hospital cardiac arrest. 7 The journal has welcomed its first experimental medicine papers. 8.…”

Section: Early Successmentioning

confidence: 99%

Resuscitation plus – Initial successes and future direction

Perkins¹,

Bray²,

Couper³

et al. 2022

Resuscitation Plus

View full text Add to dashboard Cite

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

Cited by 9 publications

References 49 publications

Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest

Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest

Effect of vasopressin and methylprednisolone vs. placebo on long-term outcomes in patients with in-hospital cardiac arrest a randomized clinical trial

Resuscitation plus – Initial successes and future direction

Contact Info

Product

Resources

About