The Thiamine Administration After Cardiac Surgery Trial
- Conditions
- Thiamine DeficiencyLactate Blood Increase
- Interventions
- Drug: Placebo
- Registration Number
- NCT04641104
- Lead Sponsor
- Sarah Saxena
- Brief 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.
- Detailed Description
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.
Thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as Wernicke's encephalopathy or Beri-Beri syndrome.
Thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. An increase in lactate levels is associated with a worse prognostic. A decrease is, on the contrary, associated with an improved prognostic, during CPR and also after cardiac arrest.
Recently, studies have shown that thiamine deficiency is underdiagnosed in ICU patients.
On top of this, extra-corporeal circulation can worsen this deficiency. This could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion Donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of ICU admission and improved mortality rates at 28 days post-ICU admission.
Therefore, the hypothesis of this study is 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thiamine Thiamine 500 MG Patients in this arm will receive a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9%. Placebo Placebo Patients in this arm will receive a solution of 100 ml of NaCl 0.9% alone.
- Primary Outcome Measures
Name Time Method Lactate 24 hours Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.
- Secondary Outcome Measures
Name Time Method Fluid balance 48 hours The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated
Inotropes 48 hours The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated
Mechanical ventilation 48 hours The influence of thiamine/ placebo on extubation time will also be evaluated.
Length of ICU stay 5 days The influence of thiamine/ placebo on ICU discharge will also be evaluated.
Length of hospital stay 30 days The influence of thiamine/ placebo on hospital discharge will also be evaluated.
Trial Locations
- Locations (1)
CHU-Charleroi Hopital Civil Marie Curie
🇧🇪Charleroi, Hainaut, Belgium