Congenital Heart Disease in ChildrenPhase 2/3NCT05579964
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
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 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Congenital Heart Disease in Children, Cardiopulmonary Bypass, Tetralogy of Fallot
- 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
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Oct 2022to 10 Jun 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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
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 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.
Read the 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).
- Being tested
- Dexmedetomidine Hcl 100 Mcg/mL Inj, Placebo
- Keywords
- Dexmedetomidine, Myocardial Protection, Tetralogy of Fallot, Total Correction, Double Blind Randomized Controlled Trial, Cardiopulmonary Bypass
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hcl 100 Mcg/mL InjDrug
Also called Precedex, Kabimidine
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
PlaceboDrug
Also called NaCl 0.9%
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
| Study group | Role | What they receive |
|---|---|---|
| DEX Group | Experimental | Priming Dexmedetomidine 0.5 mcg/kg, Infusion Dexmedetomidine 0.25 mcg/kg/hour Receives: Drug: Dexmedetomidine Hcl 100 Mcg/mL Inj |
| Control Group | Placebo comparator | NaCl 0.9% with adjusted amount and rate same as the DEX group Receives: Drug: Placebo |
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 ELABSCIENCE E-EL-H0649 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 ELABSCIENCE E-EL-H0649 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 ELABSCIENCE E-EL-H0649 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 ELABSCIENCE E-EL-H0649 reagent (ng/mL)
Measured: 24 hours after cardiopulmonary bypass (T4)
Serum IL-6 at baseline
IL-6 serum concentration will measured using RnD Quantikine D6050 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 RnD Quantikine D6050 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 RnD Quantikine D6050 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 RnD Quantikine D6050 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: 5 minutes after induction of anesthesia (T1), 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: 5 minutes after induction of anesthesia (T1), 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: 5 minutes after induction of anesthesia (T1), 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: 1 hour (T2), 6 hours (T3), 24 hours (T4) 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)
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
Measured: 7 days (or until the patient is discharge from intensive care unit)
Mortality
Mortality will be measured as long as patient is hospitalized until 30 days postoperative
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start10 Oct 2022
- Primary completion10 Apr 2023
- Study completion10 Jun 2023
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
- 66 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
- Investigators
- Dian Kesumarini, MD, Principal investigator, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579964
- Sponsor's protocol ID
- LB.02.01/Vll/011/KEP011/2022
- Other IDs
- LB.02.01/Vll/011/KEP011/2022
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2022
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT05579964
- Acronym / sponsor ID
- LB.02.01/Vll/011/KEP011/2022
- Keywords
- Dexmedetomidine, Myocardial Protection, Tetralogy of Fallot, Total Correction, Double Blind Randomized Controlled Trial, Cardiopulmonary Bypass
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 14 Oct 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX Group | Experimental | Drug: Dexmedetomidine Hcl 100 Mcg/mL InjPriming Dexmedetomidine 0.5 mcg/kg, Infusion Dexmedetomidine 0.25 mcg/kg/hour |
| Control Group | Placebo comparator | Drug: PlaceboNaCl 0.9% with adjusted amount and rate same as the DEX group |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Dexmedetomidine Hcl 100 Mcg/mL InjAlso: Precedex, KabimidinePriming 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 | Drug | DEX Group |
| PlaceboAlso: NaCl 0.9%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 | Drug | Control Group |
Primary outcome
Serum Troponin I at baseline
Time frame: 5 minutes after induction of anesthesia (T1)
Troponin I serum concentration will be measured using ELABSCIENCE E-EL-H0649 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 ELABSCIENCE E-EL-H0649 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 ELABSCIENCE E-EL-H0649 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 ELABSCIENCE E-EL-H0649 reagent (ng/mL)
Serum IL-6 at baseline
Time frame: 5 minutes after induction of anesthesia (T1)
IL-6 serum concentration will measured using RnD Quantikine D6050 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 RnD Quantikine D6050 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 RnD Quantikine D6050 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 RnD Quantikine D6050 IL-6 reagent (pg/mL)
8 secondary outcomes
Cardiac output
Time frame: 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
Cardiac Index
Time frame: 5 minutes after induction of anesthesia (T1), 6 hours (T3), 24 hours (T4), and 48 hours (T5) after cardiopulmonary bypass
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
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: 1 hour (T2), 6 hours (T3), 24 hours (T4) after cardiopulmonary bypass
Mechanical ventilation time
Time frame: 3 days (or until the patient is extubated)
Length of stay in the intensive care unit
Time frame: 7 days (or until the patient is discharge from intensive care unit)
Mortality
Time frame: 30 days post-operative
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 24 Aug 2023.
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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.
Dian Kesumarini, MD principal investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia
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 13 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 24 Aug 2023. 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 24 Aug 2023.