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Completed

NCT Number: NCT04641104

The Thiamine Administration After Cardiac Surgery Trial

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU-Charleroi Hopital Civil Marie Curie

Charleroi, Hainaut, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Thiamine 500 MG

Drug

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

Placebo

Drug

100 ml of NaCl 0.9% will be administered in the placebo group.

Primary outcomes

  1. Lactate

    Time frame: 24 hours

    Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.

Secondary outcomes

  1. Fluid balance

    Time frame: 48 hours

    The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated

  2. Inotropes

    Time frame: 48 hours

    The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated

  3. Mechanical ventilation

    Time frame: 48 hours

    The influence of thiamine/ placebo on extubation time will also be evaluated.

  4. Length of ICU stay

    Time frame: 5 days

    The influence of thiamine/ placebo on ICU discharge will also be evaluated.

  5. Length of hospital stay

    Time frame: 30 days

    The influence of thiamine/ placebo on hospital discharge will also be evaluated.

Sponsors and collaborators

Lead sponsor

Sarah Saxena

Other

Collaborators

  • CHU de Charleroi

Registry information

Acronym: TAACS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2020
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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