Clinical trial NCT03640949: Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest
Official title: Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Arrest
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2018-08-21
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. In-hospital cardiac arrest
2. Age ≥ 18 years
3. Received at least one dose of adrenaline during cardiopulmonary resuscitation

Exclusion Criteria:

1. Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
2. Prior enrollment in the trial
3. Invasive mechanical circulatory support at the time of the cardiac arrest
4. Known or suspected pregnancy at the time of the cardiac arrest

Primary outcomes:
measure: Number of Participants With Return of Spontaneous Circulation
timeFrame: During the cardiac arrest, an average of 20 minutes
Secondary outcomes:
measure: Number of Participants That Survived 30 Days
timeFrame: At 30 days
measure: Number of Participants With a Favorable Neurological Outcome at 30 Days
timeFrame: At 30 days
Other outcomes:
measure: Vasopressor-free Days
timeFrame: 7 days
measure: Invasive Ventilation-free Days
timeFrame: 7 days
measure: Sequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours
timeFrame: 24, 48 and 72 hours
measure: Hospital Disposition
timeFrame: At hospital discharge, up to 1 year
measure: Survival
timeFrame: At 90 days, 180 days, and 1 year
measure: Favorable Neurological Outcome
timeFrame: At 90 days, 180 days, and 1 year
measure: Modified Rankin Scale (mRS)
timeFrame: At 30 days, 90 days, 180 days, and 1 year
measure: Glasgow Outcome Scale Extended (GOSE)
timeFrame: At 30 days, 90 days, 180 days, and 1 year
measure: Health-related Quality of Life (EQ-5D-5L)
timeFrame: At 30 days, 90 days, 180 days, and 1 year
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital - Gentofte
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital - Køge
city: Odense
country: Denmark
facility: Odense University Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lars W Andersen, MD, MPH, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Andersen 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.