NCT04641104

The Thiamine Administration After Cardiac Surgery Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sarah Saxena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lactate Blood Increase
• Thiamine Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-20
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2020-11-23
• Last updated: 2022-11-17

Locations

1 site across 1 country: Belgium