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

NCT02618824 | Unknown Phase 2 DMC

• 1 other identifier: 01201508011
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (4)

• Change of Malondialdehyde levels

  Malondialdehyde (MDA) is the end product of lipid peroxidation by ROS results in a state of oxidative stress, and a marker of the increase in ROS in reperfusion injury. MDA concentration in plasma of patients measured by test methods thiobarbituric acid and spectrophotometric examination.

  after induction of anaesthesia, 30 minutes and 4 hours post aortic cross clamp removal

• Change of Caspase-3 levels

  Caspase-3 is a protease, a family of cysteine proteases that act as executor in the process of apoptosis, and is used as a marker of apoptosis. The expression of caspase-3 measured quantitatively by immunohistochemistry using polyclonal antibody method cleaved caspase-3 from myocardial biopsy.

  after induction of anaesthesia, 30 minutes post aortic cross clamp removal

• Cardiac Troponin I levels

  Cardiac troponin I (cTnI) s a protein involved in the process of contraction of the heart, and is only found in heart cells, which will be released into the blood circulation when heart injury. CTn-I measured with Enzyme Linked Fluorescent Assay technique. Specimens for measurement of cTnI are from whole blood or serum.

  During the first 24 hours after cross clamp removal

• Number of patients with low cardiac output syndrome

  Low cardiac output syndrome (LCOS) is a state in which clinical sign and symptoms of low cardiac output are found with or without the increasing of arterial and venous saturation gap and metabolic acidosis, the use of new inotropic, mechanical support, or other maneuvers in order to increase cardiac output. LCOS is determined by intensivist based on the clinical presentation, laboratory and inotropic scores.

  During the first 48 hours after aortic cross clamp removal

Secondary Outcomes (5)

• Inotropic Score

  During the first 72 hours post cross clamp removal

• Postoperative Time to Extubation

  up to 3 month after surgery

• Postoperative Length of Stay in Intensive Care Unit

  up to 3 month after surgery

• Postoperative Hospital Length of Stay

  up to 3 month after surgery

• All cause mortality

  up to 3 month after surgery

Study Arms (2)

HTK Solution

ACTIVE COMPARATOR

Hearts will be arrested with HTK solution during cardiac operation

Drug: Histidine Tryptophan Ketoglutarate Solution

HTK Solution + TWBC

ACTIVE COMPARATOR

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

Drug: Histidine Tryptophan Ketoglutarate Solution; Other: Terminal Warm Blood Cardioplegia

Interventions

Histidine Tryptophan Ketoglutarate Solution 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; HTK Solution + TWBC

Terminal Warm Blood Cardioplegia 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

Also known as: Hot Shot

HTK Solution + TWBC

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiac Centre Harapan Kita Hospital

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Bretschneider cardioplegic solution

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pribadi W Busro, MD

  National Cardiac Centre Harapan Kita Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pribadi W Busro, MD

CONTACT

628128820719; pribadiwb@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2015-12

Locations

ID (1)