A Phase 4 interventional study of Thiamine 500 MG and Placebo in Lactate Blood Increase and Thiamine Deficiency, sponsored by Sarah Saxena. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Sarah Saxena · Phase 4, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 200 is above the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →This is the only study on the registry with Sarah Saxena as lead sponsor.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will receive a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9%.
Drug: Thiamine 500 MG
Patients in this arm will receive a solution of 100 ml of NaCl 0.9% alone.
Drug: Placebo
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.
Also known as: Thiamine
100 ml of NaCl 0.9% will be administered in the placebo group.
Lactate
Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.
Time frame: 24 hours
Fluid balance
The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated
Time frame: 48 hours
Inotropes
The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated
Time frame: 48 hours
Mechanical ventilation
The influence of thiamine/ placebo on extubation time will also be evaluated.
Time frame: 48 hours
Length of ICU stay
The influence of thiamine/ placebo on ICU discharge will also be evaluated.
Time frame: 5 days
Length of hospital stay
The influence of thiamine/ placebo on hospital discharge will also be evaluated.
Time frame: 30 days
Plan to share: No
Ran from Nov 2020 to primary completion in Oct 2022, 22 months.
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Studies of the drug tested here: Thiamine