Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest (VAM-IHCA)
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|ClinicalTrials.gov Identifier: NCT03640949|
Recruitment Status : Completed
First Posted : August 21, 2018
Results First Posted : January 11, 2022
Last Update Posted : March 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Heart Arrest||Drug: Vasopressin, Arginine Drug: Methylprednisolone Drug: NaCl||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||501 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial|
|Actual Study Start Date :||September 17, 2018|
|Actual Primary Completion Date :||January 21, 2021|
|Actual Study Completion Date :||January 21, 2022|
Experimental: 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).
Drug: Vasopressin, Arginine
20 IE of vasopressin per dose for a maximum of four doses (80 IU)
40 mg methylprednisolone once
Placebo Comparator: 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.
- Number of Participants With Return of Spontaneous Circulation [ Time Frame: During the cardiac arrest, an average of 20 minutes ]Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
- Number of Participants That Survived 30 Days [ Time Frame: At 30 days ]
- Number of Participants With a Favorable Neurological Outcome at 30 Days [ Time Frame: At 30 days ]A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
- Vasopressor-free Days [ Time Frame: 7 days ]Vasopressor-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving vasopressors and is alive.
- Invasive Ventilation-free Days [ Time Frame: 7 days ]Invasive ventilation-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving invasive ventilation and is alive.
- Sequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours [ Time Frame: 24, 48 and 72 hours ]The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score.
- Hospital Disposition [ Time Frame: At hospital discharge, up to 1 year ]Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.
- Survival [ Time Frame: At 90 days, 180 days, and 1 year ]
- Favorable Neurological Outcome [ Time Frame: At 90 days, 180 days, and 1 year ]A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
- Modified Rankin Scale (mRS) [ Time Frame: At 30 days, 90 days, 180 days, and 1 year ]The mRS is a 7-point scale, ranging from 0 (no symptoms) to 6 (dead), assessing the degree of disability and dependence after a neurological injury such as stroke or cardiac arrest. A good outcome will be defined as a mRS of 0 to 3 and a poor outcome as 4 to 6.
- Glasgow Outcome Scale Extended (GOSE) [ Time Frame: At 30 days, 90 days, 180 days, and 1 year ]The GOSE is a 8-point scale that is an extension of the Glasgow Outcomes Scale (which is identical to the CPC, only with inverse scores) where the scores 1, 2 and 3 from the CPC score is divided into two.
- Health-related Quality of Life (EQ-5D-5L) [ Time Frame: At 30 days, 90 days, 180 days, and 1 year ]The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640949
|Aalborg University Hospital|
|Aarhus University Hospital|
|Copenhagen University Hospital - Rigshospitalet|
|Copenhagen University Hospital - Gentofte|
|Copenhagen University Hospital - Herlev|
|Horsens Regional Hospital|
|Zealand University Hospital - Køge|
|Odense University Hospital|
|Randers Regional Hospital|
|Viborg Regional Hospital|
|Principal Investigator:||Lars W Andersen, MD, MPH, PhD, DMSc||Aarhus University Hospital|