Thiamine Deficiency Clinical Trial
— TAACSOfficial title:
The Thiamine Administration After Cardiac Surgery Trial
Verified date | November 2022 |
Source | Université Libre de Bruxelles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 3, 2022 |
Est. primary completion date | October 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the CHU de Charleroi between November 2020 and December 2021. Written informed consent will be obtained from each patient/ family member participating in the study. Exclusion Criteria: - Patients already supplemented with vitamins - Patients with an allergy to thiamine - Patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively - Patients with mitochondrial disorders - Patients with Child Pugh C cirrhosis - Patients with a history of epilepsy with tonic-clonic movements postoperatively. - Pregnant patients |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU-Charleroi Hopital Civil Marie Curie | Charleroi | Hainaut |
Lead Sponsor | Collaborator |
---|---|
Sarah Saxena | CHU de Charleroi |
Belgium,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lactate | Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo. | 24 hours | |
Secondary | Fluid balance | The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated | 48 hours | |
Secondary | Inotropes | The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated | 48 hours | |
Secondary | Mechanical ventilation | The influence of thiamine/ placebo on extubation time will also be evaluated. | 48 hours | |
Secondary | Length of ICU stay | The influence of thiamine/ placebo on ICU discharge will also be evaluated. | 5 days | |
Secondary | Length of hospital stay | The influence of thiamine/ placebo on hospital discharge will also be evaluated. | 30 days |
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