Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05579964
Other study ID # LB.02.01/Vll/011/KEP011/2022
Secondary ID LB.02.01/Vll/011
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 10, 2022
Est. completion date June 10, 2023

Study information

Verified date August 2023
Source National Cardiovascular Center Harapan Kita Hospital Indonesia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Congenital heart disease (CHD) is the most common congenital abnormality found in newborns with Tetralogy of Fallot (TOF) being the most common cyanotic CHD. Total correction of TOF was performed using a cardiopulmonary bypass (CPB) machine. However, the use of CPB has a negative effect that causes inflammation and myocardial injury. Myocardial protection in patients undergoing total correction of TOF surgery is more difficult than other cyanotic CHD due to a hypertrophic right ventricular condition. Dexmedetomidine (DEX) is a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of pro-inflammatory cytokines released. Thus, the administration of DEX can prevent myocardial necrosis and apoptosis, also reducing reperfusion injury when using CPB machines. Research related to the effectiveness of administering DEX as a myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery in Indonesia is less reported. The aim of this study is to determine the effectiveness of DEX as myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery.


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).


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date June 10, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine Hcl 100 Mcg/mL Inj
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
Placebo
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

Locations

Country Name City State
Indonesia National Cardiovascular Center Harapan Kita Hospital Indonesia Jakarta

Sponsors (1)

Lead Sponsor Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Troponin I at baseline Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL) 5 minutes after induction of anesthesia (T1)
Primary Serum Troponin I at 1 hour after cardiopulmonary bypass Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL) 1 hour after cardiopulmonary bypass (T2)
Primary Serum Troponin I at 6 hours after cardiopulmonary bypass Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL) 6 hours after cardiopulmonary bypass (T3)
Primary Serum Troponin I at 24 hours after cardiopulmonary bypass Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 reagent (ng/mL) 24 hours after cardiopulmonary bypass (T4)
Primary Serum IL-6 at baseline IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL) 5 minutes after induction of anesthesia (T1)
Primary Serum IL-6 at 1 hour after cardiopulmonary bypass IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL) 1 hour after cardiopulmonary bypass (T2)
Primary Serum IL-6 at 6 hours after cardiopulmonary bypass IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL) 6 hours after cardiopulmonary bypass (T3)
Primary Serum IL-6 at 24 hours after cardiopulmonary bypass IL-6 serum concentration will measured using RnD Quantikine D6050 IL-6 reagent (pg/mL) 24 hours after cardiopulmonary bypass (T4)
Secondary Cardiac output Cardiac output will be measured using transthoracic echocardiography (L/min) 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Secondary Cardiac Index Cardiac index will be measured using transthoracic echocardiography (L/min) 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Secondary Systemic Vascular Resistance (SVR) SVR will be measured using transthoracic echocardiography (L/min) 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Secondary Serum Lactate Serum lactate will be measured using an enzymatic method with a blood gas analyzer machine (mmol/L) 5 minutes after anesthesia induction (T1), and then 1 hour (T2), 6 hours (T3), and 24 hours (T4) after cardiopulmonary bypass
Secondary VIS Score Vasoinotropic score will be measured using the VIS formula 1 hour (T2), 6 hours (T3), 24 hours (T4) after cardiopulmonary bypass
Secondary Mechanical ventilation time Mechanical ventilation time will be measured from the moment the patient arrives at the intensive care unit until the patient is extubated 3 days (or until the patient is extubated)
Secondary Length of stay in the intensive care unit 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 7 days (or until the patient is discharge from intensive care unit)
Secondary Mortality Mortality will be measured as long as patient is hospitalized until 30 days postoperative 30 days post-operative
See also
  Status Clinical Trial Phase
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Completed NCT02518087 - Increased Adsorption Membranes During Cardiopulmonary Bypass N/A
Recruiting NCT01231776 - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass N/A
Completed NCT00747331 - Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass Phase 4
Terminated NCT00176657 - The Use of HEMOBAG to Salvage Blood After Cardiac Surgery Phase 2
Completed NCT00161733 - Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery Phase 3
Completed NCT05537168 - Bayesian Networks in Pediatric Cardiac Surgery
Completed NCT05525195 - Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
Completed NCT04238806 - Desflurane,Brain Natriuretic Peptide and Cardiac Surgery N/A
Completed NCT00981474 - Cerebral Autoregulation Monitoring During Cardiac Surgery N/A
Recruiting NCT05588011 - Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass N/A
Completed NCT02566733 - Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass Phase 4
Terminated NCT00385450 - Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor Phase 1
Completed NCT00246740 - Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting Phase 2
Not yet recruiting NCT05075265 - Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
Recruiting NCT04296071 - Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Active, not recruiting NCT04133740 - Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study Phase 4
Completed NCT05033236 - Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)
Completed NCT02979158 - Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass N/A