Coronary Artery Bypass GraftingNCT05586347
Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery
A study testing Nicardipine and normal saline in people with Coronary Artery Bypass Grafting and Cardiopulmonary Bypass, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery, mainly manifested as mental confusion, anxiety, personality change and memory impairment, which seriously affects the quality of life of patients after surgery.Attention should be paid to the protection of neurological function in… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- What is being tested?
- Nicardipine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2022to 30 Sep 2022
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1: Age 60-80
- 2: ASA Ⅱ-Ⅲ, NYHAⅠ-Ⅲ, EF ≥50%
- 3: CABG under cardiopulmonary bypass
Who cannot join
- 1: Patients who had second heart surgery
- 2: Patients with intellectual disabilities, deafness or other impairments in normal communication
- 3: Previous neurosurgical procedures and history of cerebral infarction
- 4: cancer
- 5: Patients with moderate to severe carotid artery stenosis before operation
- 6: Patients with obvious abnormal liver and kidney function affecting drug metabolism
Show all 9Show fewer
- 7: Patients taking psychotropic drugs
- 8: Alcoholism, drug addiction, drug dependence
- 9: The cardiopulmonary bypass time was greater than 120 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery, mainly manifested as mental confusion, anxiety, personality change and memory impairment, which seriously affects the quality of life of patients after surgery.Attention should be paid to the protection of neurological function in patients undergoing cardiac surgery during perioperative period.Nicardipine can selectively act on coronary arteries and cerebral vessels, increase coronary artery and cerebral blood flow, relieve coronary heart disease angina pectoris, protect brain tissue.The cerebral protective effect of nicardipine on cardiovascular surgery under CPB deserves further clinical study.About 15-20% of cardiac output (CO) in healthy adults is allocated to the brain , and cerebral blood flow is supplied by bilateral internal carotid artery (ICA) and vertebral artery (VA), among which ICA provides about 70%-80% of cerebral perfusion flow .However, the location of the internal carotid artery is superficial, the anatomical variation is less, and the ultrasonic Doppler technique is portable and simple to measure. It may be of certain clinical value to use the ultrasonic detection technology to quickly evaluate the cerebral perfusion during the perioperative period, and to early detect and avoid the intraoperative brain function injury.
Read the detailed description
Patients who were scheduled to undergo open-heart surgery under cardiopulmonary bypass were randomly divided into nicardipine group (group N) and normal saline control group (group C) by the digital table method. Group N was pumped with nicardipine 0.2-0.5μg/(kg·min) after CPB, while group C was given the same volume of normal saline. The basic hemodynamic parameters, rScO2, BIS, maximum systolic velocity of internal carotid artery (PSV-ICA), end-diastolic velocity of internal carotid artery (EDV-ICA), diameter of internal carotid artery (D-ICA), internal carotid artery blood flow (Q-ICA) and cerebral blood flow ratio (CBF/CO) were observed and recorded in the two groups at each time point ), cerebrovascular resistance (CVR) and the concentration of NSE, a biomarker of brain injury.The following hypothesis is proposed: during CPB, pump nicardipine can dilate the internal carotid artery and cerebral arterioles, increase cerebral blood flow, improve cerebral oxygen supply, and reduce the risk of postoperative cognitive dysfunction（POCD）.
- Being tested
- Nicardipine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
Also called Astellas Pharmaceuticals (China) Co., LTD；Sinopharm approved number J20160048/ Registration number H20160015
Nicardipine 0.2-0.5μg/(kg·min) was infused at the beginning of CPB.
normal salineOther
Also called Hunan Kelun Pharmaceutical Co., LTD；Sinopharm approved H43020456
It has the same capacity as group N。
| Study group | Role | What they receive |
|---|---|---|
| group N | Experimental | Nicardipine was infused after initiation of CPB Receives: Drug: Nicardipine |
| group C | Placebo comparator | Give the same volume of normal saline Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal carotid blood flow
Blood flow through the internal carotid artery was measured per minute by ultrasound
Measured: Before induction of anesthesia
Internal carotid blood flow
Blood flow through the internal carotid artery was measured per minute by ultrasound
Measured: Surgical skin excision
Internal carotid blood flow
Blood flow through the internal carotid artery was measured per minute by ultrasound
Measured: During cardiopulmonary bypass
Internal carotid blood flow
Blood flow through the internal carotid artery was measured per minute by ultrasound
Measured: After cardiopulmonary bypass
Secondary outcomes (8)
Regional cerebral oxygen
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Measured: Before induction of anesthesia
Regional cerebral oxygen
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Measured: Surgical skin excision
Regional cerebral oxygen
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Measured: During cardiopulmonary bypass
Regional cerebral oxygen
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Measured: After cardiopulmonary bypass
Mini-mental State Examination scale score
Illiteracy group (no education) less than 17 points, primary school group (education ≤6 years) less than 20 points, secondary school or above group (education > 6 years) less than 24 points, the above is normal.
Measured: 1 day before surgery
Mini-mental State Examination scale score
Illiteracy group (no education) less than 17 points, primary school group (education ≤6 years) less than 20 points, secondary school or above group (education > 6 years) less than 24 points, the above is normal.
Measured: 7 days after surgery.
Neuron specific endase
3ml arterial blood was collected and centrifuged. The plasma was stored in a refrigerator at -70℃ for measurement, and the concentration of NSE was determined by ELISA.
Measured: Before induction of anesthesia
Neuron specific endase
3ml arterial blood was collected and centrifuged. The plasma was stored in a refrigerator at -70℃ for measurement, and the concentration of NSE was determined by ELISA.
Measured: 2 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start22 Apr 2022
- Primary completion22 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Shi, Nanjing First Hospital, Nanjing Medical University
- Investigators
- hongwei shi, Study director, Director of anesthesiology department of Nanjing First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586347
- Sponsor's protocol ID
- hongweishi
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05586347
- Acronym / sponsor ID
- hongweishi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 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.
Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery, mainly manifested as mental confusion, anxiety, personality change and memory impairment, which seriously affects the quality of life of patients after surgery.Attention should be paid to the protection of neurological function in patients undergoing cardiac surgery during perioperative period.Nicardipine can selectively act on coronary arteries and cerebral vessels, increase coronary artery and cerebral blood flow, relieve coronary heart disease angina pectoris, protect brain tissue.The cerebral protective effect of nicardipine on cardiovascular surgery under CPB deserves further clinical study.About 15-20% of cardiac output (CO) in healthy adults is allocated to the brain , and cerebral blood flow is supplied by bilateral internal carotid artery (ICA) and vertebral artery (VA), among which ICA provides about 70%-80% of cerebral perfusion flow .However, the location of the internal carotid artery is superficial, the anatomical variation is less, and the ultrasonic Doppler technique is portable and simple to measure. It may be of certain clinical value to use the ultrasonic detection technology to quickly evaluate the cerebral perfusion during the perioperative period, and to early detect and avoid the intraoperative brain function injury.
Detailed description
Patients who were scheduled to undergo open-heart surgery under cardiopulmonary bypass were randomly divided into nicardipine group (group N) and normal saline control group (group C) by the digital table method. Group N was pumped with nicardipine 0.2-0.5μg/(kg·min) after CPB, while group C was given the same volume of normal saline. The basic hemodynamic parameters, rScO2, BIS, maximum systolic velocity of internal carotid artery (PSV-ICA), end-diastolic velocity of internal carotid artery (EDV-ICA), diameter of internal carotid artery (D-ICA), internal carotid artery blood flow (Q-ICA) and cerebral blood flow ratio (CBF/CO) were observed and recorded in the two groups at each time point ), cerebrovascular resistance (CVR) and the concentration of NSE, a biomarker of brain injury.The following hypothesis is proposed: during CPB, pump nicardipine can dilate the internal carotid artery and cerebral arterioles, increase cerebral blood flow, improve cerebral oxygen supply, and reduce the risk of postoperative cognitive dysfunction（POCD）.
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 |
|---|---|---|
| group N | Experimental | Drug: NicardipineNicardipine was infused after initiation of CPB |
| group C | Placebo comparator | Other: normal salineGive the same volume of normal saline |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1: Age 60-80
- 2: ASA Ⅱ-Ⅲ, NYHAⅠ-Ⅲ, EF ≥50%
- 3: CABG under cardiopulmonary bypass
Key exclusion criteria (9 listed)
- 1: Patients who had second heart surgery
- 2: Patients with intellectual disabilities, deafness or other impairments in normal communication
- 3: Previous neurosurgical procedures and history of cerebral infarction
- 4: cancer
- 5: Patients with moderate to severe carotid artery stenosis before operation
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 |
|---|---|---|
| NicardipineAlso: Astellas Pharmaceuticals (China) Co., LTD；Sinopharm approved number J20160048/ Registration number H20160015Nicardipine 0.2-0.5μg/(kg·min) was infused at the beginning of CPB. | Drug | group N |
| normal salineAlso: Hunan Kelun Pharmaceutical Co., LTD；Sinopharm approved H43020456It has the same capacity as group N。 | Other | group C |
Primary outcome
Internal carotid blood flow
Time frame: Before induction of anesthesia
Blood flow through the internal carotid artery was measured per minute by ultrasound
Internal carotid blood flow
Time frame: Surgical skin excision
Blood flow through the internal carotid artery was measured per minute by ultrasound
Internal carotid blood flow
Time frame: During cardiopulmonary bypass
Blood flow through the internal carotid artery was measured per minute by ultrasound
Internal carotid blood flow
Time frame: After cardiopulmonary bypass
Blood flow through the internal carotid artery was measured per minute by ultrasound
8 secondary outcomes
Regional cerebral oxygen
Time frame: Before induction of anesthesia
Regional cerebral oxygen
Time frame: Surgical skin excision
Regional cerebral oxygen
Time frame: During cardiopulmonary bypass
Regional cerebral oxygen
Time frame: After cardiopulmonary bypass
Mini-mental State Examination scale score
Time frame: 1 day before surgery
Mini-mental State Examination scale score
Time frame: 7 days after surgery.
Neuron specific endase
Time frame: Before induction of anesthesia
Neuron specific endase
Time frame: 2 hours after surgery.
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 19 Oct 2022.
- Individual participant dataSharing planned: No
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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.
hongwei shi study director
Director of anesthesiology department of Nanjing First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicardipine and normal saline in people with Coronary Artery Bypass Grafting and Cardiopulmonary Bypass, run by Nanjing First Hospital, Nanjing Medical 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 3 inclusion and 9 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 19 Oct 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 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.
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?
Internal carotid blood flow (time frame: Before induction of anesthesia). The study lists 4 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 19 Oct 2022.