Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest
NCT ID: NCT03640949
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
501 participants
INTERVENTIONAL
2018-09-17
2022-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vasopressin and methylprednisolone
The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) 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).
Vasopressin, Arginine
20 IE of vasopressin per dose for a maximum of four doses (80 IU)
Methylprednisolone
40 mg methylprednisolone once
Placebo
The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.
NaCl
Placebo
Interventions
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Vasopressin, Arginine
20 IE of vasopressin per dose for a maximum of four doses (80 IU)
Methylprednisolone
40 mg methylprednisolone once
NaCl
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. Received at least one dose of adrenaline during cardiopulmonary resuscitation
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Lars Wiuff Andersen
OTHER
Responsible Party
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Lars Wiuff Andersen
Associate Professor
Principal Investigators
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Lars W Andersen, MD, MPH, PhD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Copenhagen University Hospital - Rigshospitalet
Copenhagen, , Denmark
Copenhagen University Hospital - Gentofte
Hellerup, , Denmark
Copenhagen University Hospital - Herlev
Herlev, , Denmark
Horsens Regional Hospital
Horsens, , Denmark
Zealand University Hospital - Køge
Køge, , Denmark
Odense University Hospital
Odense, , Denmark
Randers Regional Hospital
Randers, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Trial website
Other Identifiers
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2017-004773-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
00001
Identifier Type: -
Identifier Source: org_study_id
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