Ischemia-Reperfusion InjuryPhase 4NCT05598177
Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion Injury in Patients Undergoing Open Heart Surgery With Cardiopulmonary Bypass
A Phase 4 study testing dexmedetomidine in people with Ischemia-Reperfusion Injury, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
About 200000 cardiac operations are performed in China every year. Cardiopulmonary bypass is the basic strategy of open-heart surgery, which may lead to myocardial ischemia-reperfusion injury and low cardiac output syndrome. It will inevitably affect the patient's postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemia-Reperfusion Injury
- What is being tested?
- dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years
- American Society of Anesthesiologists(ASA) physical status of I-Ⅳ
- BMI: 18.5-28 kg/m2
- Type of operation: elective open-heart surgery with cardiopulmonary bypass
- The patient and/or family members have signed the informed consent.
Who cannot join
- Preoperative diagnosis of heart failure 、gradeⅡ-Ⅲ heart block and diabetes
- LEVF<40%
- Severe coagulation dysfunction
- Severe heart, lung, liver and kidney insufficiency
- Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
- Perioperative allogeneic blood transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion : a Randomized, Double-blind Clinical Trial
About 200000 cardiac operations are performed in China every year. Cardiopulmonary bypass is the basic strategy of open-heart surgery, which may lead to myocardial ischemia-reperfusion injury and low cardiac output syndrome. It will inevitably affect the patient's postoperative recovery. A number of studies have shown that dexmedetomidine, as an auxiliary sedative, has the effects of inhibiting stress response, antiarrhythmia and cardiac protection.Dexmedetomidine has been widely used in anesthesia in cardiac surgery. However, at present, few clinical studies pay attention to its mechanism. In this study, dexmedetomidine will be used in cardiac surgery with cardiopulmonary bypass to explore the mechanism of cardiac ischemia-reperfusion injury and the protective effect of dexmedetomidine.
- Conditions
- Ischemia-Reperfusion Injury
- Being tested
- dexmedetomidine, Placebo
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
The participant will pump dexmedetomidine at the rate of 1μg/(Kg·h) for 10 minutes at the beginning of anesthesia induction, and then maintain the pump at a rate of 0.5μg/(Kg·h) during the operation.
PlaceboDrug
The participant will pump saline without dexmedetomidine at the same speed as group D.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Experimental | The participant will be infused with dexmedetomidine during anesthesia to protect the myocardium. Receives: Drug: dexmedetomidine |
| Group R | Placebo comparator | The participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
troponin T level
the level of troponin in the participant's serum
Measured: before operation
troponin T level
the level of troponin in the participant's serum
Measured: the end of operation
troponin T level
the level of troponin in the participant's serum
Measured: when the participant returned to the ward after the operation
troponin T level
the level of troponin in the participant's serum
Measured: 24 hours after operation
troponin T level
the level of troponin in the participant's serum
Measured: 72 hours after operation
Secondary outcomes (5)
AQP4、iNOS andTNF-α level
the level of AQP4、iNOS andTNF-α in the participant's serum
Measured: before operation
AQP4、iNOS andTNF-α level
the level of AQP4、iNOS andTNF-α in the participant's serum
Measured: when blocking the ascending aorta
AQP4、iNOS andTNF-α level
the level of AQP4、iNOS andTNF-α in the participant's serum
Measured: when developing the ascending aorta
AQP4、iNOS andTNF-α level
the level of AQP4、iNOS andTNF-α in the participant's serum
Measured: when cardiopulmonary bypass is stopped
AQP4、iNOS andTNF-α level
the level of AQP4、iNOS andTNF-α in the participant's serum
Measured: the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Sep 2022
- Primary completion30 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yibin Qin, Affiliated Hospital of Nantong University
- Investigators
- Yibin Qin, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598177
- Sponsor's protocol ID
- 2022-K125
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion : a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05598177
- Acronym / sponsor ID
- 2022-K125
- Conditions
- Ischemia-Reperfusion Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 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.
About 200000 cardiac operations are performed in China every year. Cardiopulmonary bypass is the basic strategy of open-heart surgery, which may lead to myocardial ischemia-reperfusion injury and low cardiac output syndrome. It will inevitably affect the patient's postoperative recovery. A number of studies have shown that dexmedetomidine, as an auxiliary sedative, has the effects of inhibiting stress response, antiarrhythmia and cardiac protection.Dexmedetomidine has been widely used in anesthesia in cardiac surgery. However, at present, few clinical studies pay attention to its mechanism. In this study, dexmedetomidine will be used in cardiac surgery with cardiopulmonary bypass to explore the mechanism of cardiac ischemia-reperfusion injury and the protective effect of dexmedetomidine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Drug: dexmedetomidineThe participant will be infused with dexmedetomidine during anesthesia to protect the myocardium. |
| Group R | Placebo comparator | Drug: PlaceboThe participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-70 years
- American Society of Anesthesiologists(ASA) physical status of I-Ⅳ
- BMI: 18.5-28 kg/m2
- Type of operation: elective open-heart surgery with cardiopulmonary bypass
- The patient and/or family members have signed the informed consent.
Key exclusion criteria (6 listed)
- Preoperative diagnosis of heart failure 、gradeⅡ-Ⅲ heart block and diabetes
- LEVF<40%
- Severe coagulation dysfunction
- Severe heart, lung, liver and kidney insufficiency
- Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
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 |
|---|---|---|
| dexmedetomidineThe participant will pump dexmedetomidine at the rate of 1μg/(Kg·h) for 10 minutes at the beginning of anesthesia induction, and then maintain the pump at a rate of 0.5μg/(Kg·h) during the operation. | Drug | Group D |
| PlaceboThe participant will pump saline without dexmedetomidine at the same speed as group D. | Drug | Group R |
Primary outcome
troponin T level
Time frame: before operation
the level of troponin in the participant's serum
troponin T level
Time frame: the end of operation
the level of troponin in the participant's serum
troponin T level
Time frame: when the participant returned to the ward after the operation
the level of troponin in the participant's serum
troponin T level
Time frame: 24 hours after operation
the level of troponin in the participant's serum
troponin T level
Time frame: 72 hours after operation
the level of troponin in the participant's serum
5 secondary outcomes
AQP4、iNOS andTNF-α level
Time frame: before operation
AQP4、iNOS andTNF-α level
Time frame: when blocking the ascending aorta
AQP4、iNOS andTNF-α level
Time frame: when developing the ascending aorta
AQP4、iNOS andTNF-α level
Time frame: when cardiopulmonary bypass is stopped
AQP4、iNOS andTNF-α level
Time frame: the end of the operation
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 21 Mar 2024.
Related trials for Ischemia-Reperfusion Injury
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
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.
Yibin Qin study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine in people with Ischemia-Reperfusion Injury, run by Affiliated Hospital of Nantong University at 1 site in China.
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 5 inclusion and 6 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 21 Mar 2024. 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
troponin T level (time frame: before operation). The study lists 5 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 21 Mar 2024.