CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Thiamine 500 MG +1 moredrug
Likely dose
Thiamine 500 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/NCT04641104
NCT04641104Phase 4Completed
CompareCT.gov

The Thiamine Administration After Cardiac Surgery Trial

Sarah Saxena·interventional·Posted Nov 23, 2020·Updated Nov 17, 2022

In Brief

A Phase 4 clinical trial evaluating Thiamine 500 MG and Placebo for Lactate Blood Increase and Thiamine Deficiency. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose. We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLactate Blood Increase, Thiamine Deficiency
CountriesBelgium
CollaboratorsCHU de Charleroi

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedNov 23, 2020
Enrollment StartNov 20, 2020
Primary CompletionOct 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.6 years ago

Interventions

Thiamine 500 MGdrug

A solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% will be administered post-cardiac surgery in patients with lactate levels ≥ 2 mmol / L in the first 6 hours post-ICU admission.

Placebodrug

100 ml of NaCl 0.9% will be administered in the placebo group.