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Dexmedetomidine for Myocardial Protection in Pediatric TOF Surgery
NCT05579964Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2022
- Primary completion
- Apr 2023
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- tetralogy of Fallot (TOF)
01
Overview
Phase 3, randomised, double-blind trial of dexmedetomidine in tetralogy of Fallot (TOF) (2 arms), sponsored by National Cardiovascular Center Harapan Kita. Primary endpoints: Serum Troponin I and Serum Interleukin-6. Started Oct 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
DEX Group
Dexmedetomidine priming and infusion during CPB
Control Group
Placebo (NaCl 0.9%) priming and infusion during CPB
03
Who it enrols
Pediatric patients (1 month - 18 years) with classic Tetralogy of Fallot undergoing elective total correction cardiac surgery. Patients with preoperative infection, impaired liver or renal function, or coagulation disorders are excluded.
04
Endpoints
Primary
Serum Troponin I
Serum Interleukin-6
Secondary
Cardiac Output
Cardiac Index
Systemic Vascular Resistance
Serum Lactate
Vasoactive-Inotropic Score
Mechanical ventilation time
Length of stay in the intensive care unit
Mortality
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