CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Thiamine +1 moredrug
Likely dose
Thiamine 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02322892
NCT02322892Phase 2Completed
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Thiamine as an Adjunctive Therapy in Cardiac Surgery

Beth Israel Deaconess Medical Center·interventional·Posted Dec 23, 2014·Updated Mar 30, 2017

In Brief

A Phase 2 clinical trial evaluating Thiamine and Normal saline solution for Coronary Artery Bypass and Cardiac Surgical Procedures. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Bypass, Cardiac Surgical Procedures
CountriesUnited States
CollaboratorsAmerican Heart Association, University of Aarhus

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 23, 2014
Enrollment StartJan 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.5 years ago

Interventions

Thiaminedrug

200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)

Normal saline solutiondrug

50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)