Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02974257

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Shock Lactic Acidosis Thiamin Deficiency	Drug: Thiamine Other: placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Feb 7, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thiamine Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.	Drug: Thiamine Thiamine 500mg IV twice daily for 2 days Other Names: vitamin B1
Placebo Comparator: Placebo Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.	Other: placebo 100mL normal saline IV every 12 hours for 2 days Other Names: normal saline

Arm

Intervention/Treatment

Experimental: Thiamine

Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.

Drug: Thiamine

Thiamine 500mg IV twice daily for 2 days

Other Names:

vitamin B1

Placebo Comparator: Placebo

Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.

Other: placebo

100mL normal saline IV every 12 hours for 2 days

Other Names:

normal saline

Outcome Measures

Primary Outcome Measures

lactate [2 days]
The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups

Secondary Outcome Measures

oxygen consumption [2 days]
The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups
Pyruvate dehydrogenase [2 days]
The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)