Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

Heart Arrest Clinical Trial

— VAM-IHCA  

Official title:

Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640949
• Other study ID #: 00001
• Secondary ID: 2017-004773-13
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 17, 2018
• Est. completion date: January 21, 2022

Study information

• Verified date: February 2022
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Drug:
• Vasopressin, Arginine
20 IE of vasopressin per dose for a maximum of four doses (80 IU)
• Methylprednisolone
40 mg methylprednisolone once
• NaCl
Placebo

Locations

Country	Name	City	State
Denmark	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

Sponsors (2)

Lead Sponsor	Collaborator
Lars Wiuff Andersen	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vasopressor-free 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.	7 days
Other	Invasive Ventilation-free 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.	7 days
Other	Sequential Organ Failure Assessment (SOFA) Score at 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.	24, 48 and 72 hours
Other	Hospital Disposition	Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.	At hospital discharge, up to 1 year
Other	Survival		At 90 days, 180 days, and 1 year
Other	Favorable Neurological Outcome	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.	At 90 days, 180 days, and 1 year
Other	Modified Rankin Scale (mRS)	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.	At 30 days, 90 days, 180 days, and 1 year
Other	Glasgow Outcome Scale Extended (GOSE)	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.	At 30 days, 90 days, 180 days, and 1 year
Other	Health-related Quality of Life (EQ-5D-5L)	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).	At 30 days, 90 days, 180 days, and 1 year
Primary	Number of Participants With Return of Spontaneous Circulation	Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes	During the cardiac arrest, an average of 20 minutes
Secondary	Number of Participants That Survived 30 Days		At 30 days
Secondary	Number of Participants With a Favorable Neurological Outcome 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.	At 30 days

External Links

•   Trial website