Trial · NCT02322892
Thiamine as an Adjunctive Therapy in Cardiac Surgery
NCT02322892, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2017-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thiamine as an Adjunctive Therapy in Cardiac Surgery. Trials, record NCT02322892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02322892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thiamine as an Adjunctive Therapy in Cardiac Surgery
- NCT number
- NCT02322892
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Coronary Artery Bypass, Cardiac Surgical Procedures
- Interventions
- Thiamine, Normal saline solution
- First posted
- 2014-12-23
- Last updated
- 2017-03-30
- Results first posted
- 2017-03-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lactate Levels | Post-surgery within 1 hour of arrival to the ICU | |
| Secondary | Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity | Post-surgery within 1 hour of arrival to the ICU | PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery. |
| Secondary | Patients With Post-operative Complications | Until hospital discharge, limit 60 days | Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection |
| Secondary | Length of Stay | Until hospital discharge, limit 60 days | Duration of intensive care unit stay |
| Secondary | Mortality | Until hospital discharge, limit 60 days | |
| Other | Lactate Levels | Six hours after end of surgery surgery | |
| Other | Pyruvate Dehydrogenase (PDH) Enzyme Activity | Six hours after end of surgery surgery | PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method |
| Other | Time on Mechanical Ventilation | Limit 60 days | |
| Other | Time on Vasopressors | Limit 60 days | |
| Other | Global Oxygen Consumption (VO2) | From arrival to ICU to extubation, limit 6 hours | VO2 will be measured with a Compact Anesthesia monitor |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lactate Levels | Post-surgery within 1 hour of arrival to the ICU | Modified intention to treat | mmol/L | MEDIAN |
| SECONDARY | Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity | Post-surgery within 1 hour of arrival to the ICU | Percent change from baseline | MEDIAN | |
| SECONDARY | Patients With Post-operative Complications | Until hospital discharge, limit 60 days | participants | NUMBER | |
| SECONDARY | Length of Stay | Until hospital discharge, limit 60 days | days | MEDIAN | |
| SECONDARY | Mortality | Until hospital discharge, limit 60 days | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Lactate Levels | Six hours after end of surgery surgery | |||
| OTHER_PRE_SPECIFIED | Pyruvate Dehydrogenase (PDH) Enzyme Activity | Six hours after end of surgery surgery | |||
| OTHER_PRE_SPECIFIED | Time on Mechanical Ventilation | Limit 60 days | |||
| OTHER_PRE_SPECIFIED | Time on Vasopressors | Limit 60 days | |||
| OTHER_PRE_SPECIFIED | Global Oxygen Consumption (VO2) | From arrival to ICU to extubation, limit 6 hours |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lactate Levels | Control Arm | 2 | Inter-Quartile Range 1.7 to 2.4 | mmol/L | |
| Lactate Levels | Thiamine | 2.0 | Inter-Quartile Range 1.5 to 2.6 | mmol/L | |
| Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity | Control Arm | 28 | Inter-Quartile Range 15 to 84 | Percent change from baseline | |
| Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity | Thiamine | 15 | Inter-Quartile Range 11 to 37 | Percent change from baseline | |
| Patients With Post-operative Complications | Control Arm | 16 | participants | ||
| Patients With Post-operative Complications | Thiamine | 16 | participants | ||
| Length of Stay | Control Arm | 2.3 | Inter-Quartile Range 1.4 to 4.0 | days | |
| Length of Stay | Thiamine | 2.4 | Inter-Quartile Range 1.1 to 4.2 | days | |
| Mortality | Control Arm | 1 | participants | ||
| Mortality | Thiamine | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Arm | 35 | |
| Overall Study | STARTED | Thiamine | 34 | |
| Overall Study | COMPLETED | Control Arm | 33 | |
| Overall Study | COMPLETED | Thiamine | 31 | |
| Overall Study | NOT COMPLETED | Control Arm | 2 | |
| Overall Study | NOT COMPLETED | Thiamine | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Arm | ||
| Total, all-cause mortality | Thiamine | ||
| Total, other adverse events | Control Arm | 0 | 33 |
| Total, other adverse events | Thiamine | 0 | 31 |
| Total, serious adverse events | Control Arm | 0 | 33 |
| Total, serious adverse events | Thiamine | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27044557 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thiamine vs Control Arm: Mortality | Trial comparisons |
| Thiamine vs Control Arm: Patients With Post-operative Complications | Trial comparisons |
| Thiamine vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02322892
GET https://conductscience.org/api/trials/v1/NCT02322892/registered