- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05579964
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a double blind randomized controlled trial to determine the effectiveness of DEX during CPB as myocardial protection between DEX group and control group. The study population is classic TOF patients who underwent elective total correction cardiac surgery. This study was approved by the research ethical committee (Institutional Review Board) of the National Cardiovascular Center Harapan Kita Jakarta (NCCHK). Before randomization, participants who are eligible based on inclusion and exclusion criterias will be given informed consent. If the guardians of the participants agree, the participants will be included in this research. Sixty-six pediatric participants with classic TOF undergoing elective total correction will be randomly divided into two groups, DEX group and control group. Dexmedetomidine HCl is provided in the form of a liquid injection (Precedex/Kabimidine 200 mcg/2 ml). For the DEX group, DEX was calculated with a priming dose of 0.5 mcg/kg in a 5 ml syringe mixed in priming fluid and 0.25 mcg/kg/hour DEX infusion diluted in 0.9% NaCl 20 ml in a 20 ml syringe administered to the CPB reservoir with an infusion rate of 10 ml/hour. For the control group, the volume of administration of 0.9% NaCl as priming and 0.9% NaCl infusion was given to the CPB machine with adjusted amount and rate same as the DEX group.
We will measure myocardial injury biomarker plasma levels (Troponin I) and cytokines proinflammatory biomarkers plasma level (IL-6) as the primary outcome of myocardial protection. Serum plasma levels of troponin I and IL-6 will be taken 4 times (T1, 5 minutes after induction as baseline level; T2,1 hour after CPB; T3, 6 hours after CPB, and T4, 24 hours after CPB). Secondary outcomes including hemodynamic profile (cardiac output, cardiac index, and systemic vascular resistance, at 5 minute before induction as baseline level, 6 hours, 24 hours, and 48 hours after CPB), serum lactate levels at 5 minutes after induction as baseline level, 1 hour, 6 hours, and 24 hours after CPB, morbidity outcomes (vasoinotropic score at 1 hour, 6 hours, and 24 hours after CPB, length of ventilator use, and length of stay in intensive care).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Dian Kesumarini, MD
- Phone Number: +6281367697904
- Email: diankesumarini@gmail.com
Study Locations
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Jakarta, Indonesia, 11420
- National Cardiovascular Center Harapan Kita Hospital Indonesia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient's parents or person in charge is willing to participate in the study
- Patients with classic TOF undergoing elective total correction cardiac surgery
- Aged 1 month - 18 years old
Exclusion Criteria:
- The patient experiences a change in the surgical plan from elective to immediate or emergency
- Patients with preoperative infection characterized by procalcitonin >0.5ng/mL
- Patients with impaired liver function characterized by an increase in Serum Glutamic Oxaloacetic Transaminase (SGOT)/Serum Glutamic Pyruvic Transaminase (SGPT) more than 1.5 times the upper limit of normal
- Impaired renal function characterized by creatinine > 2 mg/dL
- Patients with coagulation disorders characterized by International Normalized Ratio (INR) > 1.5
Drop-out Criteria:
- Duration of CPB and/or Aortic cross-clamp time exceeding 120 minutes
- Surgery requires more than two attempts of CPB
- Patient fails to wean from CPB
- Patient requires ECMO (Extracorporeal Membrane Oxygenator) postoperatively
- Patients with postoperative reperfusion injury characterized by pulmonary hemorrhage
- Patients with residual lesions in the form of moderate-severe pulmonary stenosis and moderate-severe pulmonary regurgitation.
- Patient dies on the operating table
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DEX Group
Priming Dexmedetomidine 0.5 mcg/kg, Infusion Dexmedetomidine 0.25 mcg/kg/hour
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Priming dose of 0.5 mcg/kg in a 5 ml syringe mixed in priming fluid and 0.25 mcg/kg/hour DEX infusion diluted in 0.9% NaCl 20 ml in a 20 ml syringe administered to the CPB reservoir with an infusion rate of 10 ml/hour
Other Names:
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Placebo Comparator: Control Group
NaCl 0.9% with adjusted amount and rate same as the DEX group
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Priming dose of NaCl 0.9% in a 5 ml syringe mixed in priming fluid and NaCl 0.9% 20 ml in a 20 ml syringe administered to the CPB reservoir with an infusion rate of 10 ml/hour
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Troponin I at baseline
Time Frame: 5 minutes after induction of anesthesia (T1)
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Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL)
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5 minutes after induction of anesthesia (T1)
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Serum Troponin I at 1 hour after cardiopulmonary bypass
Time Frame: 1 hour after cardiopulmonary bypass (T2)
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Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL)
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1 hour after cardiopulmonary bypass (T2)
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Serum Troponin I at 6 hours after cardiopulmonary bypass
Time Frame: 6 hours after cardiopulmonary bypass (T3)
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Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL)
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6 hours after cardiopulmonary bypass (T3)
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Serum Troponin I at 24 hours after cardiopulmonary bypass
Time Frame: 24 hours after cardiopulmonary bypass (T4)
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Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL)
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24 hours after cardiopulmonary bypass (T4)
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Serum IL-6 at baseline
Time Frame: 5 minutes after induction of anesthesia (T1)
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IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL)
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5 minutes after induction of anesthesia (T1)
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Serum IL-6 at 1 hour after cardiopulmonary bypass
Time Frame: 1 hour after cardiopulmonary bypass (T2)
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IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL)
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1 hour after cardiopulmonary bypass (T2)
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Serum IL-6 at 6 hours after cardiopulmonary bypass
Time Frame: 6 hours after cardiopulmonary bypass (T3)
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IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL)
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6 hours after cardiopulmonary bypass (T3)
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Serum IL-6 at 24 hours after cardiopulmonary bypass
Time Frame: 24 hours after cardiopulmonary bypass (T4)
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IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL)
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24 hours after cardiopulmonary bypass (T4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output
Time Frame: 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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Cardiac output will be measured using transthoracic echocardiography (L/min)
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5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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Cardiac Index
Time Frame: 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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Cardiac index will be measured using transthoracic echocardiography (L/min)
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5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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Systemic Vascular Resistance (SVR)
Time Frame: 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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SVR will be measured using transthoracic echocardiography (L/min)
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5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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Serum Lactate
Time Frame: 5 minutes after anesthesia induction (T1), and then 1 hour (T2), 6 hours (T3), and 24 hours (T4) after cardiopulmonary bypass
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Serum lactate will be measured using an enzymatic method with a blood gas analyzer machine (mmol/L)
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5 minutes after anesthesia induction (T1), and then 1 hour (T2), 6 hours (T3), and 24 hours (T4) after cardiopulmonary bypass
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VIS Score
Time Frame: 1 hour (T2), 6 hours (T3), 24 hours (T4) after cardiopulmonary bypass
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Vasoinotropic score will be measured using the VIS formula
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1 hour (T2), 6 hours (T3), 24 hours (T4) after cardiopulmonary bypass
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Mechanical ventilation time
Time Frame: 3 days (or until the patient is extubated)
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Mechanical ventilation time will be measured from the moment the patient arrives at the intensive care unit until the patient is extubated
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3 days (or until the patient is extubated)
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Length of stay in the intensive care unit
Time Frame: 7 days (or until the patient is discharge from intensive care unit)
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Length of stay in the intensive care unit will be measured from the moment the patient is admitted to the intensive care unit after the surgery until discharge from intensive care unit
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7 days (or until the patient is discharge from intensive care unit)
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Mortality
Time Frame: 30 days post-operative
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Mortality will be measured as long as patient is hospitalized until 30 days postoperative
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30 days post-operative
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Collaborators and Investigators
Investigators
- Principal Investigator: Dian Kesumarini, MD, National Cardiovascular Center Harapan Kita Hospital Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Diseases
- Tetralogy of Fallot
- Heart Defects, Congenital
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- LB.02.01/Vll/011/KEP011/2022 (Other Identifier: National Cardiovascular Center Harapan Kita Hospital Indonesia)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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