Congenital Heart Disease in ChildrenPhase 2/3NCT05300802
The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study
A Phase 2/3 study testing Dexmedetomidine Hcl 100 Mcg/mL Inj in people with Congenital Heart Disease in Children and Cardiopulmonary Bypass, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial summary
Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD. In Indonesia, the prevalence is 43.200 out of 4.8 million births annually. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Congenital Heart Disease in Children, Cardiopulmonary Bypass
- What is being tested?
- Dexmedetomidine Hcl 100 Mcg/mL Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Dec 2021to 16 Jul 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All the patients guardian consent to participate in this study
- Patient with Cyanotic CHD who are undergoing open-heart surgery using CPB with an Aristotle score of 6-9
- Patient is aged between 1 month to 6 years
Who cannot join
- Elective surgery patients who change into an emergency case surgery
- Patient with procalcitonin levels exceeding 0.5 ng/ml with the symptoms of infection
- Patient with liver dysfunction as measured by an increase of Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) levels more than 1.5 times from baseline
- Patient with Renal dysfunction as measured by creatinine levels exceeding 2 mg/dL
- Drop out Criteria:
- Duration of CPB and/or Aortic cross-clamp time exceeding 120 minutes
Show all 11Show fewer
- Intraoperative anatomy of CHDs finding is different from the preoperative diagnosis so that the patient no longer fulfils the Aristotle score of 6-9
- Surgery requires more than two attempts of CPB
- Patient fails to wean from CPB
- Patient requires ECMO (Extracorporeal Membrane Oxygenator) postoperatively
- Patient dies on the operating table
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita Hospital Indonesia
Jakarta, 11420
About this study
Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD. In Indonesia, the prevalence is 43.200 out of 4.8 million births annually. The morbidity and mortality of cyanotic CHDs in the National Cardiovascular Center Harapan Kita (NCCHK) are higher than acyanotic CHDs. Open-heart surgery using a cardiopulmonary bypass (CPB) machine temporarily takes over the function of the heart and lung during surgery. However, the use of CPB has several negative effects such myocardial injury, systemic inflammation, and reperfusion injury. Preoperative hypoxia in cyanotic CHD tends to be associated with a higher risk of myocardial injury. Myocardial protection has an important role in attenuating those effects. Generally, we use a cardioplegia solution as myocardial protection, but there are several non-cardioplegia techniques that can be used to enhance myocardial protection during cardiac bypass, such as adding an anesthetic agent. Dexmedetomidine (DEX) is the active dextroisomer of medetomidine, 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 proinflammatory cytokines released. Research related to the priming and infusion of DEX during CPB in patients with cyanotic CHDs who are undergoing open-heart surgery is less reported. The aims of this study are to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by using two different doses compared to the control group. The population included in this study is pediatric patients with cyanotic CHD who are undergoing open-heart surgery using CPB and who classified as 6 to 9 in the Aristotle Score.
Read the detailed description
The investigators will conduct a double-blind randomized controlled trial preliminary study to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by using two different doses compared to the control group. The population included in this study will be pediatric patients with cyanotic CHD who are undergoing open-heart surgery using CPB and who classified as 6 to 9 in the Aristotle Score. 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 patients agree, the patient will be included in this research. Fifteen pediatric patients with cyanotic CHD will be randomly divided into three groups A, B, and C. Group A is the control group and will be given 50 ml Ringer acetate solution in a 50 ml syringe that will be added to the priming solution in CPB, followed by 50 ml of Ringer acetate solution administered in a syringe pump infusion running at 25 ml/hour and which will be ended by the end of CPB. Group B will received DEX 1 mcg/kg diluted in 50 ml of Ringer acetate solution in a 50 ml syringe added in the priming solution in CPB, followed by 50 ml of Ringer acetate solution administered in a syringe pump infusion running at 25 ml/hour and which will be ended by the end of CPB. Group C will be administered 0.5 mcg/kg DEX, diluted in 50 ml of Ringer acetate solution in a 50 ml syringe added in the priming solution in CPB, followed by 0.25 mcg/kg/hour DEX diluted in 50 ml of Ringer acetate solution administered in a syringe pump infusion running at 25 ml/hour infusion which will be ended by the end of CPB.
Age, gender, body weight, body length, body surface area, Aristotle scores, aortic cross-clamp time, CPB time, and operation time are included as demographics and characteristics data. The investigators will measure myocardial injury biomarker serum levels (Troponin I) and cytokines proinflammatory biomarker serum levels (IL-6) as the primary outcome of myocardial protection. Serum 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 include hemodynamic profile (Cardiac output, cardiac index, and systemic vascular resistance, at 6 hours, 24 hours, and 48 hours after CPB plus serum lactate levels at 5 minutes after induction as baseline level, 1 hour, 6 hours, and 24 hours after CPB), morbidity outcomes (the highest Vasoinotropic Score at the first 24 hours after CPB, length of mechanical ventilation, and length of intensive care stay), and adverse event occurrences such as hypotension and bradycardia (at 5 minutes after induction as baseline level, 1 hour, 6 hours, and 24 hours after CPB).
- Being tested
- Placebo, Dexmedetomidine Hcl 100 Mcg/mL Inj
- Keywords
- Dexmedetomidine, Myocardial Protection, Pediatric Cyanotic Congenital Heart Disease, Cardiopulmonary Bypass, Aristotle Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Ringer Acetate
50 ml of Ringer acetate will be added to the priming solution and followed by a continuous 50 ml infusion of Ringer acetate running at 25 ml/hour.
Dexmedetomidine Hcl 100 Mcg/mL InjDrug
Also called Kabimidine
1 mcg/kg diluted DEX will be added to the priming solution and followed by a continuous infusion of 50 ml Ringer acetate running at 25 ml/hour.
Dexmedetomidine Hcl 100 Mcg/mL InjDrug
Also called Kabimidine
0.5 mcg/kg DEX will be added to the priming solution and followed by a continuous infusion of 0.25 mcg/kg/hour DEX diluted in 50 ml of ringer acetate running at 25 ml/hour.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Ringer acetate Receives: Drug: Placebo |
| Group B | Experimental | Priming Dexmedetomidine 1 mcg/kg, Intravenous Ringer acetate Receives: Drug: Dexmedetomidine Hcl 100 Mcg/mL Inj |
| Group C | Experimental | Priming Dexmedetomidine 0.5 mcg/kg, Intravenous Dexmedetomidine 0.25 mcg/kg/hour Receives: Drug: Dexmedetomidine Hcl 100 Mcg/mL Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Troponin I at baseline
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Measured: 5 minutes after induction of anesthesia (T1)
Serum Troponin I at 1 hour after cardiopulmonary bypass
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Measured: 1 hour after cardiopulmonary bypass (T2)
Serum Troponin I at 6 hours after cardiopulmonary bypass
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Measured: 6 hours after cardiopulmonary bypass (T3)
Serum Troponin I at 24 hours after cardiopulmonary bypass
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Measured: 24 hours after cardiopulmonary bypass (T4)
Serum IL-6 at baseline
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Measured: 5 minutes after induction of anesthesia (T1)
Serum IL-6 at 1 hour after cardiopulmonary bypass
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Measured: 1 hour after cardiopulmonary bypass (T2)
Serum IL-6 at 6 hours after cardiopulmonary bypass
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Measured: 6 hours after cardiopulmonary bypass (T3)
Serum IL-6 at 24 hours after cardiopulmonary bypass
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Measured: 24 hours after cardiopulmonary bypass (T4)
Secondary outcomes (8)
Cardiac output
Cardiac output will be measured using transthoracic echocardiography (L/min)
Measured: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Cardiac Index
Cardiac index will be measured using transthoracic echocardiography (L/min)
Measured: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Systemic Vascular Resistance (SVR)
SVR will be measured using transthoracic echocardiography (L/min)
Measured: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Serum Lactate
Serum lactate will be measured using an enzymatic method with a blood gas analyzer machine (mmol/L)
Measured: 5 minutes after anesthesia induction (T1), and then 1 hour (T2), 6 hours (T3), and 24 hours (T4) after cardiopulmonary bypass
VIS Score
Vasoinotropic score will be measured using the VIS formula
Measured: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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
Measured: 3 days (or until the patient is extubated)
Hospital length of stay in the intensive care unit
Hospital 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
Measured: 7 days (or until the patient is discharge from intensive care unit)
Adverse effects of DEX related to the hemodynamic profile ( hypotension and bradycardia)
Adverse effects of DEX related to the hemodynamic profile ( hypotension and bradycardia)
Measured: 5 minutes after anesthesia induction (T1), and then 1 hour (T2), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start16 Dec 2021
- Primary completion16 May 2022
- Study completion16 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dian Kesumarini, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300802
- Sponsor's protocol ID
- LB.02.01/VII/581/KEP058/2021
- Other IDs
- LB.02.01/VII/581/KEP058/2021
- Status last verified
- Sep 2022
- First submitted
- 20 Dec 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study
- ClinicalTrials.gov ID
- NCT05300802
- Acronym / sponsor ID
- LB.02.01/VII/581/KEP058/2021
- Keywords
- Dexmedetomidine, Myocardial Protection, Pediatric Cyanotic Congenital Heart Disease, Cardiopulmonary Bypass, Aristotle Score
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 Jul 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD. In Indonesia, the prevalence is 43.200 out of 4.8 million births annually. The morbidity and mortality of cyanotic CHDs in the National Cardiovascular Center Harapan Kita (NCCHK) are higher than acyanotic CHDs. Open-heart surgery using a cardiopulmonary bypass (CPB) machine temporarily takes over the function of the heart and lung during surgery. However, the use of CPB has several negative effects such myocardial injury, systemic inflammation, and reperfusion injury. Preoperative hypoxia in cyanotic CHD tends to be associated with a higher risk of myocardial injury. Myocardial protection has an important role in attenuating those effects. Generally, we use a cardioplegia solution as myocardial protection, but there are several non-cardioplegia techniques that can be used to enhance myocardial protection during cardiac bypass, such as adding an anesthetic agent. Dexmedetomidine (DEX) is the active dextroisomer of medetomidine, 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 proinflammatory cytokines released. Research related to the priming and infusion of DEX during CPB in patients with cyanotic CHDs who are undergoing open-heart surgery is less reported. The aims of this study are to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by using two different doses compared to the control group. The population included in this study is pediatric patients with cyanotic CHD who are undergoing open-heart surgery using CPB and who classified as 6 to 9 in the Aristotle Score.
Detailed description
The investigators will conduct a double-blind randomized controlled trial preliminary study to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by using two different doses compared to the control group. The population included in this study will be pediatric patients with cyanotic CHD who are undergoing open-heart surgery using CPB and who classified as 6 to 9 in the Aristotle Score. 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 patients agree, the patient will be included in this research. Fifteen pediatric patients with cyanotic CHD will be randomly divided into three groups A, B, and C. Group A is the control group and will be given 50 ml Ringer acetate solution in a 50 ml syringe that will be added to the priming solution in CPB, followed by 50 ml of Ringer acetate solution administered in a syringe pump infusion running at 25 ml/hour and which will be ended by the end of CPB. Group B will received DEX 1 mcg/kg diluted in 50 ml of Ringer acetate solution in a 50 ml syringe added in the priming solution in CPB, followed by 50 ml of Ringer acetate solution administered in a syringe pump infusion running at 25 ml/hour and which will be ended by the end of CPB. Group C will be administered 0.5 mcg/kg DEX, diluted in 50 ml of Ringer acetate solution in a 50 ml syringe added in the priming solution in CPB, followed by 0.25 mcg/kg/hour DEX diluted in 50 ml of Ringer acetate solution administered in a syringe pump infusion running at 25 ml/hour infusion which will be ended by the end of CPB.
Age, gender, body weight, body length, body surface area, Aristotle scores, aortic cross-clamp time, CPB time, and operation time are included as demographics and characteristics data. The investigators will measure myocardial injury biomarker serum levels (Troponin I) and cytokines proinflammatory biomarker serum levels (IL-6) as the primary outcome of myocardial protection. Serum 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 include hemodynamic profile (Cardiac output, cardiac index, and systemic vascular resistance, at 6 hours, 24 hours, and 48 hours after CPB plus serum lactate levels at 5 minutes after induction as baseline level, 1 hour, 6 hours, and 24 hours after CPB), morbidity outcomes (the highest Vasoinotropic Score at the first 24 hours after CPB, length of mechanical ventilation, and length of intensive care stay), and adverse event occurrences such as hypotension and bradycardia (at 5 minutes after induction as baseline level, 1 hour, 6 hours, and 24 hours after CPB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: PlaceboRinger acetate |
| Group B | Experimental | Drug: Dexmedetomidine Hcl 100 Mcg/mL InjPriming Dexmedetomidine 1 mcg/kg, Intravenous Ringer acetate |
| Group C | Experimental | Drug: Dexmedetomidine Hcl 100 Mcg/mL InjPriming Dexmedetomidine 0.5 mcg/kg, Intravenous Dexmedetomidine 0.25 mcg/kg/hour |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All the patients guardian consent to participate in this study
- Patient with Cyanotic CHD who are undergoing open-heart surgery using CPB with an Aristotle score of 6-9
- Patient is aged between 1 month to 6 years
Key exclusion criteria (11 listed)
- Elective surgery patients who change into an emergency case surgery
- Patient with procalcitonin levels exceeding 0.5 ng/ml with the symptoms of infection
- Patient with liver dysfunction as measured by an increase of Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) levels more than 1.5 times from baseline
- Patient with Renal dysfunction as measured by creatinine levels exceeding 2 mg/dL
- Duration of CPB and/or Aortic cross-clamp time exceeding 120 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Ringer Acetate50 ml of Ringer acetate will be added to the priming solution and followed by a continuous 50 ml infusion of Ringer acetate running at 25 ml/hour. | Drug | Group A |
| Dexmedetomidine Hcl 100 Mcg/mL InjAlso: Kabimidine1 mcg/kg diluted DEX will be added to the priming solution and followed by a continuous infusion of 50 ml Ringer acetate running at 25 ml/hour. | Drug | Group B |
| Dexmedetomidine Hcl 100 Mcg/mL InjAlso: Kabimidine0.5 mcg/kg DEX will be added to the priming solution and followed by a continuous infusion of 0.25 mcg/kg/hour DEX diluted in 50 ml of ringer acetate running at 25 ml/hour. | Drug | Group C |
Primary outcome
Serum Troponin I at baseline
Time frame: 5 minutes after induction of anesthesia (T1)
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Serum Troponin I at 1 hour after cardiopulmonary bypass
Time frame: 1 hour after cardiopulmonary bypass (T2)
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Serum Troponin I at 6 hours after cardiopulmonary bypass
Time frame: 6 hours after cardiopulmonary bypass (T3)
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Serum Troponin I at 24 hours after cardiopulmonary bypass
Time frame: 24 hours after cardiopulmonary bypass (T4)
Troponin I serum concentration will be measured using RnD Quantikine reagent (ng/mL)
Serum IL-6 at baseline
Time frame: 5 minutes after induction of anesthesia (T1)
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Serum IL-6 at 1 hour after cardiopulmonary bypass
Time frame: 1 hour after cardiopulmonary bypass (T2)
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Serum IL-6 at 6 hours after cardiopulmonary bypass
Time frame: 6 hours after cardiopulmonary bypass (T3)
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
Serum IL-6 at 24 hours after cardiopulmonary bypass
Time frame: 24 hours after cardiopulmonary bypass (T4)
IL-6 serum concentration will measured using an Elecsys IL-6 reagent (pg/mL)
8 secondary outcomes
Cardiac output
Time frame: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Cardiac Index
Time frame: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Systemic Vascular Resistance (SVR)
Time frame: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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
VIS Score
Time frame: 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Mechanical ventilation time
Time frame: 3 days (or until the patient is extubated)
Hospital length of stay in the intensive care unit
Time frame: 7 days (or until the patient is discharge from intensive care unit)
Adverse effects of DEX related to the hemodynamic profile ( hypotension and bradycardia)
Time frame: 5 minutes after anesthesia induction (T1), and then 1 hour (T2), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine Hcl 100 Mcg/mL Inj in people with Congenital Heart Disease in Children and Cardiopulmonary Bypass, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Troponin I at baseline (time frame: 5 minutes after induction of anesthesia (T1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.