NCT02974257

Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption and high lactate are associated with worse outcome. Thiamine is a B vitamin necessary to maintain the body's ability to use oxygen effectively, and the investigators have found that many patients are thiamine deficient after cardiac arrest. The investigators have also found that thiamine can decrease lactate in thiamine-deficient patients who are critically ill. Patients in this study will be randomized to receive either thiamine or placebo every 12 hours for 2 days after surviving an in-hospital cardiac arrest. The investigators will measure oxygen consumption continuously during that time with a monitor attached to the ventilator tubing, and will also measure lactate and other lab values at several time points.

Conditions

• Cardiac Arrest
• Shock
• Lactic Acidosis
• Thiamin Deficiency

Interventions

Type	Name	Description
DRUG	Thiamine	Thiamine 500mg IV twice daily for 2 days
OTHER	placebo	100mL normal saline IV every 12 hours for 2 days

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-02-07
• Completion: 2022-08-01
• First posted: 2016-11-28
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study