Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04641104
Study type Interventional
Source Université Libre de Bruxelles
Contact
Status Completed
Phase Phase 4
Start date November 20, 2020
Completion date October 3, 2022

See also
  Status Clinical Trial Phase
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT03263442 - High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT05663164 - Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS) N/A
Withdrawn NCT03122678 - Thiamine Supplementation in Patients With Septic Shock Phase 1
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
Completed NCT03626337 - Thiamine Responsive Disorders (TRD) Among Infants in Lao PDR
Completed NCT05390086 - Further Development and Assessment of Tools to Measure Risk Factors for and Treatment of Thiamine Deficiency Disorders
Recruiting NCT05480943 - Prevalence of Thiamine Deficiency in Hospitalized Non-Alcoholic Veterans
Active, not recruiting NCT04453761 - Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass Phase 4
Completed NCT03746106 - The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine Phase 4
Completed NCT03554668 - Systemic Inflammatory Response: Thiamine and Magnesium Status (Sir TaM Study)
Completed NCT01524315 - Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery Phase 4
Completed NCT03616288 - Trial of Thiamine Supplementation in Cambodia N/A
Completed NCT02464865 - Thiamin Deficiency in Obese Thai Children Phase 4
Completed NCT03228030 - Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial Phase 1