- ICH GCP
- US Clinical Trials Registry
- 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
February 17, 2016 updated by: Pribadi W Busro, MD, National Cardiovascular Center Harapan Kita Hospital Indonesia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pribadi W Busro, MD
- Phone Number: 628128820719
- Email: pribadiwb@gmail.com
Study Locations
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-
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Jakarta, Indonesia, 11420
- Recruiting
- National Cardiac Centre Harapan Kita Hospital
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Principal Investigator:
- Pribadi W Busro, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HTK Solution
Hearts will be arrested with HTK solution during cardiac operation
|
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
|
Active Comparator: HTK Solution + TWBC
Hearts will be arrested with HTK solution during cardiac operation and received terminal warm blood cardioplegia before aortic cross clamp removal.
|
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 (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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Malondialdehyde levels
Time Frame: after induction of anaesthesia, 30 minutes and 4 hours post aortic cross clamp removal
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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.
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after induction of anaesthesia, 30 minutes and 4 hours post aortic cross clamp removal
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Change of Caspase-3 levels
Time Frame: after induction of anaesthesia, 30 minutes post aortic cross clamp removal
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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.
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after induction of anaesthesia, 30 minutes post aortic cross clamp removal
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Cardiac Troponin I levels
Time Frame: During the first 24 hours after cross clamp removal
|
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.
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During the first 24 hours after cross clamp removal
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Number of patients with low cardiac output syndrome
Time Frame: During the first 48 hours after aortic cross clamp removal
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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.
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During the first 48 hours after aortic cross clamp removal
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inotropic Score
Time Frame: During the first 72 hours post cross clamp removal
|
Inotropic score is a method for determining the use of inotropic drugs used by the patient.
inotropic scores obtained by the following formula: Wernowsky IS = dose dopamine (mcg/kg/min) + dose dobutamine (mcg/kg/min) + 100 x doses of epinephrine (mcg/kg/min)
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During the first 72 hours post cross clamp removal
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Postoperative Time to Extubation
Time Frame: up to 3 month after surgery
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up to 3 month after surgery
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Postoperative Length of Stay in Intensive Care Unit
Time Frame: up to 3 month after surgery
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up to 3 month after surgery
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Postoperative Hospital Length of Stay
Time Frame: up to 3 month after surgery
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up to 3 month after surgery
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All cause mortality
Time Frame: up to 3 month after surgery
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up to 3 month after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pribadi W Busro, MD, National Cardiac Centre Harapan Kita Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 23, 2015
First Submitted That Met QC Criteria
November 27, 2015
First Posted (Estimate)
December 1, 2015
Study Record Updates
Last Update Posted (Estimate)
February 19, 2016
Last Update Submitted That Met QC Criteria
February 17, 2016
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01201508011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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