Status:
COMPLETED
The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study
Lead Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Conditions:
Congenital Heart Disease in Children
Cardiopulmonary Bypass
Eligibility:
All Genders
1-6 years
Phase:
PHASE2
PHASE3
Brief Summary
Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD. In Indonesia, t...
Detailed Description
The investigators will conduct a double-blind randomized controlled trial preliminary study to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by usi...
Eligibility Criteria
Inclusion
- All the patients guardian consent to participate in this study
- Patient with Cyanotic CHD who are undergoing open-heart surgery using CPB with an Aristotle score of 6-9
- Patient is aged between 1 month to 6 years
Exclusion
- Elective surgery patients who change into an emergency case surgery
- Patient with procalcitonin levels exceeding 0.5 ng/ml with the symptoms of infection
- Patient with liver dysfunction as measured by an increase of Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) levels more than 1.5 times from baseline
- Patient with Renal dysfunction as measured by creatinine levels exceeding 2 mg/dL
- Drop out Criteria:
- Duration of CPB and/or Aortic cross-clamp time exceeding 120 minutes
- Intraoperative anatomy of CHDs finding is different from the preoperative diagnosis so that the patient no longer fulfils the Aristotle score of 6-9
- Surgery requires more than two attempts of CPB
- Patient fails to wean from CPB
- Patient requires ECMO (Extracorporeal Membrane Oxygenator) postoperatively
- Patient dies on the operating table
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05300802
Start Date
December 16 2021
End Date
July 16 2022
Last Update
September 28 2022
Active Locations (1)
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1
National Cardiovascular Center Harapan Kita Hospital Indonesia
Jakarta, Indonesia, 11420