Status:
COMPLETED
Thiamine Supplementation in High Risk Cardiac Surgery Patients
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia in high risk cardiac surgery patients
Detailed Description
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...
Eligibility Criteria
Inclusion
- Valve surgery + CABG that required cardiac surgery with CPB
- Aged 18 years or older
- Signed informed consent
Exclusion
- Emergency surgery
- Chronic kidney disease of G4-G5 categories according to KDIGO criteria (at least one of the following present for \> 3 months: glomerular filtration rate ≤ 29 ml/min/1.73 m2, history of kidney transplantation)
- Known allergy to thiamine
- Pregnancy
- Current enrollment into another RCT (in the last 30 days)
- Previous enrollment and randomisation into the APPLY trial
- Administration of thiamine in the previous 30 day
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03306732
Start Date
October 19 2017
End Date
June 18 2018
Last Update
June 27 2018
Active Locations (1)
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1
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Russia