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

NCT02618824 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-02-19

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

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

OTHER

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

Sponsors & Collaborators

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    lead OTHER

Principal Investigators

  • Pribadi W Busro, MD · National Cardiac Centre Harapan Kita Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02618824 on ClinicalTrials.gov