Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Russia
NCT Number: NCT03306732
This pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia in high risk cardiac surgery patients
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Novosibirsk, Russia
Thiamine has a pivotal role and is an essential cofactor for pyruvate dehydrogenase activity. Widely known wet beri-beri is developed due to thiamine deficiency and characterized by vasodilatory shock and despaired oxygen extraction leading to kidney, heart and central nervous system dysfunction. Thiamine deficiency is often underestimated and even in primary absence of vitamin B1 deficiency, high-consumptive state of many critical illness and cardiac surgery itself can lead to its lack. Reported that in patients on chronic dialysis and patients with AKI requiring RRT thiamine deficiency is a usual finding. In cross-sectional observational study it has been shown that up to 33% of patients with a diagnosis of congestive heart failure (CHF) had thiamine deficiency due to chronic loop diuretic use. Also reported that 96% of patients (21 of 23) with heart failure receiving loop diuretic therapy (daily dose: 80-240 mg furosemide) developed thiamine deficiency. In prospective observational trial it has been shown that plasma thiamine levels were decreased after CABG surgery.
In a secondary analysis of a randomized, double-blind, placebo-controlled trial conducted in septic patients, thiamine supplementation showed highly-promising renal protective effect. Need for RRT was 8 patients (21%) in placebo group and 1 patient (3%) in thiamine group (p=0.04).
On the other hand it was unable to show any benefit of thiamine supplementation in patients undergoing CABG surgery. Although, postoperative oxygen consumption was significantly increased among patients receiving thiamine.
Nevertheless, existing evidence suggests that thiamine supplementation might be an attractive strategy in counteracting organ dysfunction and thus morbidity and mortality in high-risk cardiac surgical patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 month
Recruitment of trial patients: successful recruitment is defined as 2 patients per week on average
Time frame: 8 month
Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients
Time frame: 3 days
dosage of vasoinotropic agents and total vasopressor/norepinephrine equivalent dose
Time frame: 48 hours
Time frame: 3 days
Time frame: 30 days
Time frame: 48 hours
Time frame: 30 days
Time frame: 30 days
The safety of high dose IV thiamine supplementation will be evaluated by comparison of adverse, serious adverse events and routinely assessed biochemical parameters (i.e. complete blood count, coagulation parameters, standard biochemistry, etc.)
Time frame: 8 month
We expect that loss of follow up will not exceed 5% and data loss less than 10%
Time frame: 7 days
Time frame: 30 days
Meshalkin Research Institute of Pathology of Circulation
Network
Acronym: APPLY
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