Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia
Tahapan Penelitian : Recruit
Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Mitra Pelaksana:
CRDF
No Registry
INA-Z758Y83
Tanggal Input Registry : 29-03-2015
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-06-2014 |
| Outcome Primer | Intubation time All patients after undergoing congenital heart surgery will be supported by mechanical ventilation. Duration of this support on mechanical ventilation after surgery will be assessed in the treatment group and placebo group. Thyroid supplementation will increase the cardiac function and will make the patients extubated early than the patients without supplementation. |
| Outcome Skunder | Inotropic score and vasoactive-inotropic score The amount of inotropic drugs are calculated and reviewed serially since cross clamp removal until all drugs are stopped. |
| Descriptive Information | |
| Judul Penelitian Popular | Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia |
| Judul Penelitian Ilmiah | Tetronine (Sodium Liothyronine) for Children Undergoing Cardiopulmonary Bypass in Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Experimental: Tetronine Oral T3 (Tetronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours Intervention: Drug: Tetronine Placebo Comparator: Placebo Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours Intervention: Drug: Placebo |
| Jumlah Subyek Penelitian | 220 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Children undergoing cardiopulmonary bypass - Age 3 years old or less - Aristotle score 6 and above - Total correction or biventricular repairExclusion Criteria: - Single ventricle defects - Body weight less than 2 kg at the time of recruitment - Presentation with sepsis - Tachyarrhythmia or any other arrhythmia before surgery - Creatinine level of more than 2 mg/dL - Known thyroid disease - Known lung abnormalities (incl. infection) before surgery. |
| Administrative Information | |
| Nomor Persetujuan Etik | - |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | - |
| Contact Person | Eva M Marwali,MD, National Cardiovascular Center Harapan Kita Hospital Indonesia |