Brain ExcitabilityNCT05001425
Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
An observational study of Brain Excitability and Postoperative Delirium, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Excitability, Postoperative Delirium, Cardiac Surgery
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients undergoing heart valve replacement surgery with cardiopulmonary bypass
Who may be able to join
- ASA Ⅱ - Ⅲ;
- No cognitive impairment was assessed one day before surgery;
- Patients undergoing elective heart valve replacement under CPB and signed informed consent.
Who cannot join
- Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
- Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
- Inability to communicate with language impairment or major hearing or visual impairment;
- Liver function child-pugh Grade C, severe liver dysfunction;
- Severe renal insufficiency requires preoperative renal replacement therapy;
- A past history of intraoperative knowledge.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Xinli Ni, PhD,MD, 86-951-674-3252, xinlini6@yahoo.com
About this study
Official title: Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass: a Prospective Cohort Study
The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium
Read the detailed description
Delirium is the most common surgical patients postoperative complications of brain dysfunction. Delirium is a kind of consciousness attention and cognitive function changes of acute brain dysfunction, with volatility and reversibility of postoperative delirium (POD), increased hospital costs and length of hospital stay and mortality rate, and can lower the quality of life, lead to long-term postoperative cognitive dysfunction and dementia. The incidence of postoperative cognitive dysfunction in patients undergoing cardiac valve replacement under cardiopulmonary bypass (CPB) can be as high as 44-53%. However, since the specific mechanism of POD is still not clear, there is still a lack of effective prevention and treatment measures. Therefore, early detection and identification are helpful for the early treatment of POD.When brain injury occurs, the levels of excitatory neurotransmitters (glutamate and aspartate) will rise in a short period of time, and the high concentration of glutamate causes excessive intracellular calcium flow, causing cellular calcium overload, and generating excitatory cytotoxic effects. And abnormal electroencephalogram (EEG) is a kind of due to brain excitability/inhibitory amino acid imbalance caused by brain excitability increased result in abnormal discharge mode, can affect cognitive awareness and activities. Increased brain excitability is harmful to the potential, should avoid to happen. At present, the relationship between brain excitability and POD is still in exploring. Therefore, it is important to clarify the correlation between brain excitability and POD in patients undergoing cardiac valve replacement under CPB for improving the pathogenesis of POD.
- Conditions
- Brain Excitability, Postoperative Delirium, Cardiac Surgery
- Keywords
- Brain excitability, Postoperative Delirium, Abnormal EEG, Excitatory amino acid, Heart valve replacement surgery
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of delirium after cardiac surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
Measured: The first day after surgery
The incidence of delirium after cardiac surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
Measured: The second day after surgery
The incidence of delirium after cardiac surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
Measured: The third day after surgery
Abnormal EEG during surgery
The EEG was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist, to identify whether the EEG of the patient was epileptic discharge and burst suppression during anesthesia
Measured: Complete EEG information from entry to exit of the operating room
Plasma excitatory amino acid levels
Venous blood 5ml was collected and centrifuged (3500r/min,10min)，sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.
Measured: Before the operation after entering the operating room (baseline)
Plasma excitatory amino acid levels
Venous blood 5ml was collected and centrifuged (3500r/min,10min)，sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.
Measured: Immediately after surgery
Plasma excitatory amino acid levels
Venous blood 5ml was collected and centrifuged (3500r/min,10min)，sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.
Measured: 24 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 posted12 Aug 2021
- Study start1 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ExcitabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinli Ni, doctor, Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001425
- Sponsor's protocol ID
- LN 2021-1
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 12 Aug 2021
- 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05001425
- Acronym / sponsor ID
- LN 2021-1
- Conditions
- Brain Excitability, Postoperative Delirium, Cardiac Surgery
- Keywords
- Brain excitability, Postoperative Delirium, Abnormal EEG, Excitatory amino acid, Heart valve replacement surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 12 Aug 2021 (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.
The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium
Detailed description
Delirium is the most common surgical patients postoperative complications of brain dysfunction. Delirium is a kind of consciousness attention and cognitive function changes of acute brain dysfunction, with volatility and reversibility of postoperative delirium (POD), increased hospital costs and length of hospital stay and mortality rate, and can lower the quality of life, lead to long-term postoperative cognitive dysfunction and dementia. The incidence of postoperative cognitive dysfunction in patients undergoing cardiac valve replacement under cardiopulmonary bypass (CPB) can be as high as 44-53%. However, since the specific mechanism of POD is still not clear, there is still a lack of effective prevention and treatment measures. Therefore, early detection and identification are helpful for the early treatment of POD.When brain injury occurs, the levels of excitatory neurotransmitters (glutamate and aspartate) will rise in a short period of time, and the high concentration of glutamate causes excessive intracellular calcium flow, causing cellular calcium overload, and generating excitatory cytotoxic effects. And abnormal electroencephalogram (EEG) is a kind of due to brain excitability/inhibitory amino acid imbalance caused by brain excitability increased result in abnormal discharge mode, can affect cognitive awareness and activities. Increased brain excitability is harmful to the potential, should avoid to happen. At present, the relationship between brain excitability and POD is still in exploring. Therefore, it is important to clarify the correlation between brain excitability and POD in patients undergoing cardiac valve replacement under CPB for improving the pathogenesis of POD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients undergoing heart valve replacement surgery with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- ASA Ⅱ - Ⅲ;
- No cognitive impairment was assessed one day before surgery;
- Patients undergoing elective heart valve replacement under CPB and signed informed consent.
Key exclusion criteria (6 listed)
- Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
- Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
- Inability to communicate with language impairment or major hearing or visual impairment;
- Liver function child-pugh Grade C, severe liver dysfunction;
- Severe renal insufficiency requires preoperative renal replacement therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of delirium after cardiac surgery
Time frame: The first day after surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
The incidence of delirium after cardiac surgery
Time frame: The second day after surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
The incidence of delirium after cardiac surgery
Time frame: The third day after surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
Abnormal EEG during surgery
Time frame: Complete EEG information from entry to exit of the operating room
The EEG was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist, to identify whether the EEG of the patient was epileptic discharge and burst suppression during anesthesia
Plasma excitatory amino acid levels
Time frame: Before the operation after entering the operating room (baseline)
Venous blood 5ml was collected and centrifuged (3500r/min,10min)，sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.
Plasma excitatory amino acid levels
Time frame: Immediately after surgery
Venous blood 5ml was collected and centrifuged (3500r/min,10min)，sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.
Plasma excitatory amino acid levels
Time frame: 24 hours after surgery
Venous blood 5ml was collected and centrifuged (3500r/min,10min)，sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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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.
Xinli Ni, doctor study chair
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Excitability and Postoperative Delirium, run by General Hospital of Ningxia 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 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinli Ni, doctor (86-951-674-3252, xinlini6@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of delirium after cardiac surgery (time frame: The first day after surgery). The study lists 7 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 12 Aug 2021.