Clinical Trial: Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: change in oxygen consumption [ Time Frame: 2 days ]

The investigators will evaluate the change in oxygen consumption over the two days of the study period, compared between groups


Original Primary Outcome: change in oxygen consumption [ Time Frame: 2 days ]

We will evaluate the change in oxygen consumption over the two days of the study period, compared between groups


Current Secondary Outcome:

  • lactate [ Time Frame: 2 days ]
    The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups
  • Central venous oxygen saturation [ Time Frame: 2 days ]
    The investigators will evaluate the absolute level and the change in central venous oxygen saturation over two days, compared between groups


Original Secondary Outcome:

  • lactate [ Time Frame: 2 days ]
    We will evaluate the absolute level and the change in lactate over two days, compared between groups
  • Central venous oxygen saturation [ Time Frame: 2 days ]
    We will evaluate the absolute level and the change in central venous oxygen saturation over two days, compared between groups


Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: November 23, 2016
Date Started: May 2017
Date Completion: August 2021
Last Updated: April 10, 2017
Last Verified: April 2017