Status:
TERMINATED
Thiamine as a Metabolic Resuscitator After Cardiac Arrest
Lead Sponsor:
Michael Donnino
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and bioma...
Detailed Description
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and bioma...
Eligibility Criteria
Inclusion
- Adult patient (age ≥ 18 years)
- Cardiac arrest occurring with sustained (\> 20 minutes) return of spontaneous circulation (ROSC)
- Within 4.5 hours of cardiac arrest event
- Lactate \>/=3
Exclusion
- Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
- Traumatic etiology of arrest
- Comfort measures only or anticipated withdrawal of support within 24 hours
- Protected populations (pregnant women, prisoners)
- Known allergy to thiamine
Key Trial Info
Start Date :
May 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2022
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03450707
Start Date
May 6 2018
End Date
February 19 2022
Last Update
August 24 2023
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215