Phase 2
N=69
Thiamine as an Adjunctive Therapy in Cardiac Surgery
Coronary Artery Bypass · Cardiac Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT02322892 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Lactate Levels — 2; 2.0 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thiamine (Drug); Normal saline solution (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactate Levels |
— | — |
| SECONDARY Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity |
28; 15 | — |
| SECONDARY Patients With Post-operative Complications |
16; 16 | — |
| SECONDARY Length of Stay |
2.3; 2.4 | — |
| SECONDARY Mortality |
1; 0 | — |
Summary
The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo.
The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Adult (≥ 21 years)
- Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
- EuroSCORE II > 1.5%
Exclusion Criteria
- Current thiamine supplementation
- Known allergy to thiamine
- Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)
- Research-protected populations (pregnant women, prisoners, the intellectually disabled)
- Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)
- Off-pump surgery (i.e. surgery without cardiopulmonary bypass)
Data sourced from ClinicalTrials.gov (NCT02322892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.