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Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Phase 2
Terminated
Conditions
Lactic Acidosis
Thiamin Deficiency
Cardiac Arrest
Shock
Interventions
Other: placebo
Registration Number
NCT02974257
Lead Sponsor
Beth Israel Deaconess Medical Center
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 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
41
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ThiamineThiamineIntervention: 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.
PlaceboplaceboIntervention: 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.
Primary Outcome Measures
NameTimeMethod
Lactate2 days

The investigators will evaluate the median lactate level over two days, compared between groups

Secondary Outcome Measures
NameTimeMethod
Oxygen Consumption2 days

The investigators will evaluate the mean oxygen consumption over two days, compared between groups

Pyruvate Dehydrogenase2 days

The investigators will evaluate the median pyruvate dehydrogenase levels over two days, compared between groups

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

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