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The Thiamine Administration After Cardiac Surgery Trial

NCT04641104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-11-17

No results posted yet for this study

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.

Conditions

  • Lactate Blood Increase
  • Thiamine Deficiency

Interventions

DRUG

Thiamine 500 MG

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • CHU de Charleroi

    collaborator OTHER

  • Sarah Saxena

    lead OTHER

Principal Investigators

  • MIchael Piagnerelli, MD; PHD · CHU de Charleroi, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2022-10-03
Completion
2022-10-03

Countries

  • Belgium

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641104 on ClinicalTrials.gov