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VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial (VAST-A)

Primary Purpose

Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial

Status
Recruiting
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Vasopressin; Methylprednisolone; Hydrocortisone
Sodium chloride
Sponsored by
Tiohundra AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sahlgrenska University HospitalRecruiting
  • TiohundraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Adrenaline, vasopressin and steroids arm (intervention) At randomization 1 ml of vasopressin 20 IU/ml will be administered as soon as possible after adrenaline during the five first cycles of drug administration during CPR. 1 ml metylprednisolone sodium succinate 40 mg/ml will be administered only during the first cycle of drug administration during CPR In the ICU Hydrocortisone 3 mg/ml At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml (300 mg hydrocortisone/ d) for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the hydrocortisone dos will be reduced daily to 67 ml (200 mg) and 33 ml (100 mg) and then discontinued). Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml (300mg hydrocortisone/ d) for maximum 3 days to prevent retardation of infarct healing.

Adrenaline alone arm (control) At randomization 1 ml sodium chloride 9 mg/ml (placebo) will be administered as soon as possible after adrenaline during the first five cycle of drug administration during CPR 1 ml sodium chloride 9 mg/ml (placebo) will be administered only during the first cycle of drug administration during CPR b In the ICU sodium chloride 9 mg/ml (placebo) At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the dos will be reduced daily to 67 ml and 33 ml and then discontinued. Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml for 3 days.

Outcomes

Primary Outcome Measures

Survival at 30 days
Survival at 30 days

Secondary Outcome Measures

Full Information

First Posted
November 17, 2021
Last Updated
January 19, 2022
Sponsor
Tiohundra AB
Collaborators
Sahlgrenska University Hospital, Sweden, Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05139849
Brief Title
VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
Acronym
VAST-A
Official Title
VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tiohundra AB
Collaborators
Sahlgrenska University Hospital, Sweden, Stockholm South General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Adrenaline, vasopressin and steroids arm (intervention) At randomization 1 ml of vasopressin 20 IU/ml will be administered as soon as possible after adrenaline during the five first cycles of drug administration during CPR. 1 ml metylprednisolone sodium succinate 40 mg/ml will be administered only during the first cycle of drug administration during CPR In the ICU Hydrocortisone 3 mg/ml At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml (300 mg hydrocortisone/ d) for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the hydrocortisone dos will be reduced daily to 67 ml (200 mg) and 33 ml (100 mg) and then discontinued). Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml (300mg hydrocortisone/ d) for maximum 3 days to prevent retardation of infarct healing.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Adrenaline alone arm (control) At randomization 1 ml sodium chloride 9 mg/ml (placebo) will be administered as soon as possible after adrenaline during the first five cycle of drug administration during CPR 1 ml sodium chloride 9 mg/ml (placebo) will be administered only during the first cycle of drug administration during CPR b In the ICU sodium chloride 9 mg/ml (placebo) At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the dos will be reduced daily to 67 ml and 33 ml and then discontinued. Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml for 3 days.
Intervention Type
Drug
Intervention Name(s)
Vasopressin; Methylprednisolone; Hydrocortisone
Intervention Description
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 improving mortality. Steroids have therefore also been suggested for cardiac arrest treatment. The potential role in resuscitation includes the catecholaminerg potentiation, vasoconstriction and protection from reperfusion injury.
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Intervention Description
Sodium chloride 9 mg/ml
Primary Outcome Measure Information:
Title
Survival at 30 days
Description
Survival at 30 days
Time Frame
Survival at 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized men > 18 years and hospitalized women > 50 years. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sune Forsberg, MD, PhD
Phone
+46722037953
Email
sune.forsberg@tiohundra.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sune Forsberg, MD, PhD
Organizational Affiliation
Tiohundra AB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Lundgren, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Lundgren, MD, PhD
Phone
+46706678316
Email
peter.lundgren@vgregion.se
Facility Name
Tiohundra
City
Norrtälje
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sune Forsberg
Phone
+46722037953
Email
sune.forsberg@tiohundra.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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