Cardiac Arrest Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.
Verified date | August 2022 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate in patients who initially survive an in-hospital cardiac arrest. Patients who are successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical ventilation in the intensive care unit will be enrolled, and will get either thiamine or placebo. Their oxygen consumption and lactate will be measured at serial time points and compared between groups. The investigators' hypothesis is that thiamine will help restore the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in oxygen consumption and a decrease in lactate.
Status | Terminated |
Enrollment | 36 |
Est. completion date | August 1, 2022 |
Est. primary completion date | February 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient (age > 18 years) - Cardiac arrest occurring while admitted to the hospital, with sustained (>20 minutes) return of spontaneous circulation (ROSC) - Mechanically ventilated at the time of enrollment - Within 12 hours of cardiac arrest event Exclusion Criteria: - 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 - Comfort measures only or anticipated withdrawal of support within 24 hours - Severe agitation - Protected populations (pregnant women, prisoners) |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lactate | The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups | 2 days | |
Secondary | oxygen consumption | The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups | 2 days | |
Secondary | Pyruvate dehydrogenase | The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups | 2 days |
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