Thiamine as a Metabolic Resuscitator After Cardiac Arrest
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/8/2018 |
Start Date: | May 6, 2018 |
End Date: | February 2023 |
Contact: | Michael W Donnino, MD |
Email: | mdonnino@bidmc.harvard.edu |
Phone: | 617-754-2341 |
This is a randomized, double-blind, placebo controlled study to investigate the effect of
intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen
consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).
.
intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen
consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).
.
This is a randomized, double-blind, placebo controlled study to investigate the effect of
intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen
consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).
Patients who have sustained return of spontaneous circulation (ROSC) after OHCA and have a
lactate of 3 or greater will be eligible for the study. Enrolled patients will be randomized
to intravenous thiamine 500mg twice daily for 5 doses or matching placebo (100cc normal
saline). Blood will be drawn at several time points and patients will be connected to a
noninvasive monitor for continuous measurement of global oxygen consumption. The primary
endpoint is change in lactate level. Secondary endpoints include change in pyruvate
dehydrogenase activity, change in cellular and global oxygen consumption, change in NSE and
S100 (biomarkers of neurologic injury) and CPC-E score (a score that assesses neurologic and
functional impairment) at hospital discharge, 30 and 90 days.
intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen
consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).
Patients who have sustained return of spontaneous circulation (ROSC) after OHCA and have a
lactate of 3 or greater will be eligible for the study. Enrolled patients will be randomized
to intravenous thiamine 500mg twice daily for 5 doses or matching placebo (100cc normal
saline). Blood will be drawn at several time points and patients will be connected to a
noninvasive monitor for continuous measurement of global oxygen consumption. The primary
endpoint is change in lactate level. Secondary endpoints include change in pyruvate
dehydrogenase activity, change in cellular and global oxygen consumption, change in NSE and
S100 (biomarkers of neurologic injury) and CPC-E score (a score that assesses neurologic and
functional impairment) at hospital discharge, 30 and 90 days.
Inclusion Criteria:
- Adult patient (age ≥ 18 years)
- Cardiac arrest occurring with sustained (> 20 minutes) return of spontaneous
circulation (ROSC)
- Within 4.5 hours of cardiac arrest event
- Lactate >/=3
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
- Traumatic etiology of arrest
- Comfort measures only or anticipated withdrawal of support within 24 hours
- Protected populations (pregnant women, prisoners)
- Known allergy to thiamine
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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