VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial

Обзор

This is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. The estimated study project period runs over 3-4 years, including pilot phase. Based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. In hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current ERC guidelines are eligible for randomization in the study. Informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. Therefore, all hospitalized men \> 18 years and women \> 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (WOCBP)) and do not resuscitate (DNR) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. Only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized. Patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control). Primary outcome is survival at 30 days.

Вмешательства

• Препарат Vasopressin; Methylprednisolone; Hydrocortisone
  Vasopressin, the vasoconstrictive hypophysal hormone, alone has not shown increased survival when compared to adrenaline. However, animal data have shown increased diastolic pressure, cerebral perfusion pressure and cerebral oxygenation in cardiac arrest treatment with vasopressin, and have when compared to adrenaline been associated with better cerebral blood flow. Corticosteroids are currently used in septic shock treatment as a means to reduce time to shock reversal and thereby potentially i
• Препарат Sodium chloride
  Sodium chloride 9 mg/ml

Первичные конечные точки

• Survival at 30 days [Срок оценки: Survival at 30 days]

Критерии участия

Критерии включения

• Hospitalized men > 18 years and hospitalized women > 50 years.

Критерии исключения

• Patients not capable to comprehend information to decide about participation in the study
• Women considered of childbearing potential (WOCBP) i. e. premenopausal women
• Patients with do not resuscitate (DNR) descision
• Prior enrollment and randomization in the trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Швеция · 2 центра

• Sahlgrenska University Hospital — Gothenburg
• Tiohundra — Norrtälje

Публикации

• Andersen LW, Holmberg MJ, Hoybye M, Isbye D, Kjaergaard J, Darling S, Zwisler ST, Larsen JM, Rasmussen BS, Iversen K, Schultz M, Sindberg B, Fink Valentin M, Granfeldt A. Vasopressin and methylprednisolone and hemodynamics after in-hospital cardiac arrest - A post hoc analysis of the VAM-IHCA trial. Resuscitation. 2023 Oct;191:109922. doi: 10.1016/j.resuscitation.2023.109922. Epub 2023 Aug 3. PMID 37543161

Идентификаторы

NCT: NCT05139849 · VAST-A.Studyprotocol.Version_4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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