A Phase 2 interventional study of Thiamine and placebo in Cardiac Arrest, Shock and Lactic Acidosis, sponsored by Beth Israel Deaconess Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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-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.
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's enrollment of 41 is below the median of 100 across 518 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
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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
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
Thiamine 500mg IV twice daily for 2 days
Also known as: vitamin B1
100mL normal saline IV every 12 hours for 2 days
Also known as: normal saline
Lactate
The investigators will evaluate the median lactate level over two days, compared between groups
Time frame: 2 days
Oxygen Consumption
The investigators will evaluate the mean oxygen consumption over two days, compared between groups
Time frame: 2 days
Pyruvate Dehydrogenase
The investigators will evaluate the median pyruvate dehydrogenase levels over two days, compared between groups
Time frame: 2 days
| Milestone | Thiamine | Placebo |
|---|---|---|
| Started | 21 | 20 |
| Completed | 18 | 18 |
| Not completed | 3 | 2 |
| Withdrew: Transitioned to comfort-measures only prior to meeting fraction of inspired oxygen (fio2) criteria | 1 | 0 |
| Withdrew: Clinical indication for thiamine | 1 | 0 |
| Withdrew: Already on thiamine | 1 | 0 |
| Withdrew: Extubated prior to study drug | 0 | 1 |
| Withdrew: Death | 0 | 1 |
The investigators will evaluate the median lactate level over two days, compared between groups
| mmol/L | Thiamine | Placebo |
|---|---|---|
| Lactate | 1.9 (1.1 to 7.5) | 1.8 (1.2 to 5.4) |
The investigators will evaluate the mean oxygen consumption over two days, compared between groups
| Area under the Curve VO2 (mL/kg/min) | Thiamine | Placebo |
|---|---|---|
| Oxygen Consumption | 3.83 ± 0.94 | 3.48 ± 1.27 |
The investigators will evaluate the median pyruvate dehydrogenase levels over two days, compared between groups
| mini OD unit/min/mg protein | Thiamine | Placebo |
|---|---|---|
| Pyruvate Dehydrogenase | 1.2 (0.9 to 1.5) | 1.1 (1.0 to 1.3) |
Collected over From enrollment to time of hospital discharge or 90 days, whichever is first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Thiamine | 12/18 (66.7%) | 0/18 (0%) | 0/18 (0%) |
| Placebo | 12/18 (66.7%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Thiamine | Placebo | Total |
|---|---|---|---|
| Median | 69 (63 to 76) | 72.5 (66 to 77) | 69.5 (65 to 77) |
| Sex: Female, Male(Participants) | Thiamine | Placebo | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 12 | 12 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Thiamine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 11 | 14 | 25 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Race/Ethnicity, Customized(Participants) | Thiamine | Placebo | Total |
|---|---|---|---|
| Race — White | 7 | 9 | 16 |
| Race — Black | 3 | 4 | 7 |
| Race — Asian | 2 | 0 | 2 |
| Race — Other/Not Reported | 6 | 5 | 11 |
| Initial Rhythm(Participants) | Thiamine | Placebo | Total |
|---|---|---|---|
| Pulseless Electrical Activity | 13 | 12 | 25 |
| Asystole | 1 | 2 | 3 |
| Ventricular Fibrillation/Pulseless Ventricular Tachycardia | 4 | 4 | 8 |
| Minutes to Return of Spontaneous Circulation (ROSC)(minutes) | Thiamine | Placebo | Total |
|---|---|---|---|
| Median | 11 (6 to 15) | 10.5 (6 to 15) | 11 (6 to 15) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2017 to primary completion in Feb 2022, 57 months.
Results were first posted in Apr 2025, 3 years 2 months after primary completion.
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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thiamine
Beth Israel Deaconess Medical Center →