Congenital Heart Disease Clinical Trial
Official title:
Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Congenital Heart Disease Surgery With Cardiopulmonary Bypass Procedure and Oral Thyroid Supplementation
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.
All patients who undergo open cardiac surgery for their congenital heart disease on the
research period will be recruited consecutively and evaluated according to the study
criteria. Parents or guardians were explained about the procedure. Agreement will be
concluded by signing the informed consent. Baseline data including age, nutritional status,
diagnosis, types of heart disease (cyanotic or acyanotic), restrictive or non restrictive
pulmonary blood flow heart disease, pre-surgical peripheral saturation, pulmonary
hypertension and any syndromes associated with heart disease will be recorded on the study
sheets.
Patients will be randomised using block randomisation procedure with a block size of 4 on
treatment and control group. Included participants will be marked by specific randomisation
number by a research assistant physician who is not involved in patients' management. A
pharmacist will acquire and open a prepared envelope containing the randomisation number. The
patients, parents/guardians, research physicians, other physicians or paramedics involved in
patients' treatment will be blinded.
Placebo (Intravenous Normal Saline) and intravenous thiamine (2 mg/kg) will be administered
at induction time, 1 hours after surgery and once everyday for three days by pharmacist
according to randomization result. All subject are given oral T3 supplementation (1 mcg/kg)
every 6 hours by pharmacist as research protocol. Oral T3 supplementations are given every 6
hours, started from induction time until 11 doses (60 hours until the first dose). Drugs is
diluted with 2.5 cc aqua and administerednisterd using nasogastric tube.
Blood will be withdrawn from arterial line access for 2.5 cc in order to test thiamine,
lactate, and pyruvate concentration, as well as, measuring LDH and PDH activity. Thiamine
will be examined from blood plasma using liquid chromatography tandem mass spectometry.
Thiamine concentration below ≤ 7 nmol/L is considered low. PDH will be examined from
Peripheral Blood Mononuclear Cells (PBMCs) which will be isolated from fresh blood. PDH
activity will be tested after breaking cell membrane to initiate mitochondria lysis, this
process will be done by immunocapture and micro-plate based assay. Lactate and pyruvate
measurement will be tested using an enzymatic kit specific for lactate and pyruvate called
Sigma Aldrich reagent. Thiamine concentration, lactate concentration, pyruvate concentration,
LDH and PDH activity is going to be measured at 4 time; induction time, one hour, 24 hours,
72 hours after aortic clamp removal.
Measurement of blood gas analysis, blood glucose, central vein saturation and oxygen
extraction ratio will be performed at induction time, 1 hours, and 12 hours post-surgery.
Organ functions evaluation was performed by serially measuring SGOT and SGPT (liver function)
as well as ureum and creatinine (renal function) on ICU admission.
Echocardiography evaluation will be done on the first, second and third day after surgery to
assess the patient's ejection fraction, stroke volume, cardiac volume and index, tricuspid
annular plane systolic excursion (TAPSE), left heart diastolic functions and SVRI
calculation. It will be done by 2 research cardiologists.
Post-surgical managements will be decided according to the paediatric ICU National
Cardiovascular Center Harapan Kita treatment protocols. Inotropic concentration will be
evaluated by inotropic and vasoactive-inotropic scoring every 6 hours in the first 24 hours
and every 12 hours after the second and third 24 hours. The amount of diuretics used will be
calculated 72 hours after ICU admission. Peritoneal dialysis and continuous veno-venous
hemofiltration (CVVH) is going to be assessed by means of the length of therapy, renal
function and fluid balance. Decision to extubate will be carried out by a physician
responsible according to the treatment protocols. Every reintubation is going to be recorded
as number and length of intubation. The length of ICU and hospital stay and mortality will be
evaluated in both study groups.
Operative data such as Aristotle score, residual lesions presence, open thorax on ICU
admission, CPB duration, Aox duration and a number of procedures during CPB including
ultrafiltration, hypothermia and hemodilution is going to be recorded in the research sheets.
History of medication used which may interfere with the function of thyroid such as steroids,
dopamine and amiodarone will also be recorded.
There will be one physician who know the subject's allocation. This physician is not involve
in any kind of patients' treatment and act as the study supervisor to evaluate if any
suspicion on drug adverse reactions occurred. Drug adverse reaction is going to be monitored
by evaluating heart rhythm, heart rate, blood pressure and peripheral temperature for every 6
hours in the first 24 hours and every 12 hours in the second and third 24 hours of ICU
treatment. The criteria of drug adverse reaction are stated in the adverse effects form; they
are tachycardia, arrhythmia, hypertension and refractory hyperthermia. Any suspicion of the
presence of drug adverse effect is going to be recorded in the form and reported to the
supervising doctor for further analysis. Management on this reaction will be done by the ICU
treating doctor
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