Role of Terminal Warm Blood Cardioplegia as Myocardial Protection in the Use of Histidine-Tryptophan-Ketoglutarate Cardioplegia in Complex Congenital Heart Surgery

NCT ID: NCT02618824

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HTK Solution

Hearts will be arrested with HTK solution during cardiac operation

Group Type: ACTIVE_COMPARATOR

Histidine Tryptophan Ketoglutarate Solution

Intervention Type: DRUG

Hearts will be arrested with Histidine Tryptophan Ketoglutarate (HTK) solution during cardiac operation. After aortic cross clamp 50-60 ml/kg HTK will be administered

HTK Solution + TWBC

Hearts will be arrested with HTK solution during cardiac operation and received terminal warm blood cardioplegia before aortic cross clamp removal.

Group Type: ACTIVE_COMPARATOR

Histidine Tryptophan Ketoglutarate Solution

Intervention Type: DRUG

Hearts will be arrested with Histidine Tryptophan Ketoglutarate (HTK) solution during cardiac operation. After aortic cross clamp 50-60 ml/kg HTK will be administered

Terminal Warm Blood Cardioplegia

Intervention Type: OTHER

Terminal warm blood cardioplegia (TWBC) contains 20% HTK solution and 80% blood from cardiopulmonary bypass machine. Before aortic cross clamp removal 10-15 ml/kg TWBC will be administered with temperature 34-36 oCelcius

Interventions

Histidine Tryptophan Ketoglutarate Solution

Hearts will be arrested with Histidine Tryptophan Ketoglutarate (HTK) solution during cardiac operation. After aortic cross clamp 50-60 ml/kg HTK will be administered

Intervention Type: DRUG

Terminal Warm Blood Cardioplegia

Terminal warm blood cardioplegia (TWBC) contains 20% HTK solution and 80% blood from cardiopulmonary bypass machine. Before aortic cross clamp removal 10-15 ml/kg TWBC will be administered with temperature 34-36 oCelcius

Intervention Type: OTHER

Other Intervention Names

Hot Shot

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)

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Pribadi W Busro, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pribadi W Busro, MD

Role: PRINCIPAL_INVESTIGATOR

National Cardiac Centre Harapan Kita Hospital

Locations

National Cardiac Centre Harapan Kita Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Pribadi W Busro, MD

Role: CONTACT

pribadiwb@gmail.com

628128820719

Other Identifiers

01201508011

Identifier Type: -

Identifier Source: org_study_id