Clinical trial NCT02618824: Role of Terminal Warm Blood Cardioplegia as Myocardial Protection in the Use of Histidine-Tryptophan-Ketoglutarate Cardioplegia in Complex Congenital Heart Surgery
Official title: Role of Terminal Warm Blood Cardioplegia as Myocardial Protection in the Use of Histidine-Tryptophan-Ketoglutarate Cardioplegia in Complex Congenital Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Congenital Heart Disease
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 110
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Terminal warm blood cardioplegia (TWBC) has been shown to enhance myocardial protection in adult patients. Even in pediatric patients, the use of cold blood cardioplegia followed by administration of TWBC will provide cardioprotective effect similar to adult patients. Histidine-tryptophan-ketoglutarate (HTK), is attractive for cardiac surgeons because it is administered as a single dose and is claimed to offer myocardial protection for a period of up to 180 minutes allowing performance of complex procedures without interruption. Merging the use of TWBC on the use of HTK cardioplegia, especially for pediatric cardiac cases, have not been investigated. This technique is expected to provide a longer ischemic time and a protective effect against reperfusion injury.

Detailed description: The design of this study is a randomized controlled trial in children younger than 5 years old undergoing heart surgery with cardiopulmonary bypass. The objective of this study is to assess the role of TWBC in use of HTK cardioplegia compared with the use of HTK cardioplegia alone in open heart surgery of complex congenital heart disease. This study will be conducted at the National Cardiac Centre Harapan Kita Hospital Indonesia. Surgery will be performed in the operating room of Pediatric and Congenital Cardiac Surgery Unit. This study uses non-probability consecutive sampling. The samples are all pediatric patients with complex congenital heart disease who meet the inclusion criteria and not excluded by the exclusion criteria. Patients will be divided into two groups, the treatment group who received HTK cardioplegia and TWBC, and the control group that only received HTK cardioplegia alone. Hearts will be arrested with HTK solution during cardiac operation. HTK cardioplegia will be given through the aortic root at a dose of 50-60 ml/kg after aortic cross-clamped. For the treatment group, TWBC will be given shortly before the aortic cross clamp is removed at a dose of 10 to 15 ml/kg with temperature of 34 to 36 oCelcius. TWBC is a mixture of blood and HTK kardioplegia with a composition of four to one. The outcomes of this study are malondialdehyde as a marker of reperfusion injury due to oxidative stress, caspase-3 as a marker of apoptosis, cTn-I as a marker of myocardial cell damage and the incidence of low cardiac output syndrome.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with complex cyanotic congenital heart disease who scheduled for pediatric cardiac surgery
* Aristotle score is 8 and above
* Parents of patient have written informed consent and agree to follow the research procedures

Exclusion Criteria:

* Patient diagnosed with an other congenital defect
* Patient diagnosed with rare congenital heart defect and high mortality rate (such as hypoplastic left heart syndrome)

Primary outcomes:
measure: Change of Malondialdehyde levels
timeFrame: after induction of anaesthesia, 30 minutes and 4 hours post aortic cross clamp removal
measure: Change of Caspase-3 levels
timeFrame: after induction of anaesthesia, 30 minutes post aortic cross clamp removal
measure: Cardiac Troponin I levels
timeFrame: During the first 24 hours after cross clamp removal
measure: Number of patients with low cardiac output syndrome
timeFrame: During the first 48 hours after aortic cross clamp removal
Secondary outcomes:
measure: Inotropic Score
timeFrame: During the first 72 hours post cross clamp removal
measure: Postoperative Time to Extubation
timeFrame: up to 3 month after surgery
measure: Postoperative Length of Stay in Intensive Care Unit
timeFrame: up to 3 month after surgery
measure: Postoperative Hospital Length of Stay
timeFrame: up to 3 month after surgery
measure: All cause mortality
timeFrame: up to 3 month after surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiac Centre Harapan Kita Hospital
Study officials:
affiliation: National Cardiac Centre Harapan Kita Hospital
name: Pribadi W Busro, MD
role: PRINCIPAL_INVESTIGATOR
References: