Clinical trial NCT04641104: The Thiamine Administration After Cardiac Surgery Trial
Official title: The Thiamine Administration After Cardiac Surgery Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lactate Blood Increase
Thiamine Deficiency
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
Collaborators: name: CHU de Charleroi
First posted: 2020-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a monocentric randomized, controlled, double blind study in patients undergoing elective cardiac surgery with extra corporal circulation. Anesthesia management of these patients is standardised in terms of volume-controlled ventilation, fluid and inotropes management.

Randomization of 100 patients for the administration, of a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% versus a solution of 100 ml of NaCl 0.9% alone in adult patients (≥ 18 years-old) with a lactate ≥ 2 mmol / L in the first 6 hours of ICU admission.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactate
timeFrame: 24 hours
Secondary outcomes:
measure: Fluid balance
timeFrame: 48 hours
measure: Inotropes
timeFrame: 48 hours
measure: Mechanical ventilation
timeFrame: 48 hours
measure: Length of ICU stay
timeFrame: 5 days
measure: Length of hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: CHU-Charleroi Hopital Civil Marie Curie
state: Hainaut
Study officials:
affiliation: CHU de Charleroi, Belgium
name: MIchael Piagnerelli, MD; PHD
role: PRINCIPAL_INVESTIGATOR
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