UnknownPhase 4

Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass

Indonesia50 participantsStarted 2018-07-01

Plain-language summary

This is a randomized, double-blind, controlled trial design. It was conducted with a main purpose of evaluating the effect of thiamine supplementation on serum lactate and lactate-pyruvate ratio after surgery as direct indicators of tissue perfusion and indirect markers of energy substrate availability for effective mitochondrial function and intubation time as clinical outcome.

Who can participate

Age range1 Month – 2 Years

SexALL

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Exclusion criteria

✕. Body weight of less than 2 kg at the study period
✕. Suffering from pre-surgical tachyarrhythmia or other types of arrhythmias
✕. Pre-surgical sepsis
✕. Serum creatinine of more than 2 mg/dL
✕. Diagnosed with thyroid abnormalities prior to the surgery

What they're measuring

Evaluate the effect of thiamine supplementation to pyruvate levels

Timeframe: at 6 hours post cross clamp removal

Trial details

NCT IDNCT04453761

SponsorNational Cardiovascular Center Harapan Kita Hospital Indonesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Thiamine Deficiency trials