Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/11/2018 |
| Start Date: | May 1, 2017 |
| End Date: | August 2021 |
| Contact: | Katherine M Berg, MD |
| Email: | kberg@bidmc.harvard.edu |
| Phone: | 617-667-5864 |
Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.
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.
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.
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.
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.
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)
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Katherine M Berg, MD
Phone: 617-667-5864
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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