CHU-Charleroi Hopital Civil Marie Curie
Charleroi, Hainaut, Belgium
NCT Number: NCT04641104
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Charleroi, Hainaut, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Thiamine
100 ml of NaCl 0.9% will be administered in the placebo group.
Time frame: 24 hours
Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.
Time frame: 48 hours
The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated
Time frame: 48 hours
The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated
Time frame: 48 hours
The influence of thiamine/ placebo on extubation time will also be evaluated.
Time frame: 5 days
The influence of thiamine/ placebo on ICU discharge will also be evaluated.
Time frame: 30 days
The influence of thiamine/ placebo on hospital discharge will also be evaluated.
Sarah Saxena
Other
Acronym: TAACS
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