Delirium, PostoperativePhase 3NCT06361238
Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery
A Phase 3 study testing Liraglutide injection in people with Delirium, Postoperative, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- Liraglutide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Type 2 diabetes
- Patients undergoing elective cardiac surgery
Who cannot join
- History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc
- Patients with communication difficulties, such as severe visual, auditory, or speech impairments
- History of central nervous system damage or surgery
- Cardiac function NYHA Class IV
- Severe liver dysfunction (Child-Pugh Class C)
- Severe renal failure requiring renal replacement therapy
Show all 14Show fewer
- History of pancreatitis
- Type 1 diabetes
- Patients whose blood sugar is difficult to control within 4-8 mmol/L during the screening period
- Patients with medullary thyroid carcinoma or a family history of it
- Pregnant or breastfeeding women
- Intolerance or allergy to liraglutide
- Previous use of GLP-1A and SGLT2i
- Patients who refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wenxue liu
Nanjing, Jiangsu, 210000
Wenxue NA Liu, MD$PHD, +8615751866806, diligent_hi@163.com
About this study
Official title: Perioperative Application of Liraglutide for the Prevention of Postoperative Delirium Among Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery: a Single-Center Randomized Controlled Study
This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery.
Read the detailed description
Delirium is the most prevalent neurological complication following cardiac surgery. It is characterized by an acute and fluctuating disturbance in consciousness, attention, and cognitive function. The incidence of delirium post-cardiac surgery ranges between 11% and 46%. It is closely linked to increased postoperative mortality, extended hospital stays, higher healthcare costs, and long-term cognitive impairment. Currently, it is widely recognized that the development of delirium is influenced by multiple factors, including advanced age, diabetes, surgical and anesthetic techniques, depression, baseline cognitive function, and infections, among others.
Inflammatory responses, crucial for protecting against external or internal threats, can, following surgery, lead to neuroinflammation and neurological damage due to elevated postoperative inflammatory markers and blood-brain barrier disruption. The involvement of microglia and astrocytes, key players in the central nervous system's immune response, has been identified in mediating postoperative delirium, making them potential targets for prevention.
Liraglutide, a Glucagon-like peptide-1 receptor agonist primarily used for treating Type 2 diabetes, has shown promise in mitigating neurocognitive damage associated with diabetes and Alzheimer's disease, suggesting its potential in preventing postoperative delirium in cardiac surgery patients with Type 2 diabetes. Preliminary animal studies and a randomized controlled trial indicate that perioperative liraglutide application could reduce the incidence of postoperative delirium by inhibiting glial activation and the subsequent neuroinflammatory response. However, differences in patient demographics, disease severity, and dosing in previous studies highlight the need for further investigation.
The study aims to investigate whether the perioperative administration of liraglutide can prevent the onset of postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. Secondary objectives include assessing the impact on the severity and duration of delirium, cognitive function, anxiety, depression, cardiac function, cardiovascular events, ICU stay, mechanical ventilation duration, and levels of serum markers for brain injury, inflammation, myocardial damage, and cardiac function.
- Conditions
- Delirium, Postoperative
- Being tested
- Liraglutide injection, Placebo injection
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide injectionDrug
Also called Victoza
Subcutaneous injection of liraglutide: 0.6 mg administered the day before surgery, 1.8 mg administered post-anesthesia induction on the day of surgery, followed by 0.6 mg daily for the first three postoperative days.
Placebo injectionDrug
Also called Normal saline
Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide Group | Experimental | Subcutaneous injection of liraglutide Receives: Drug: Liraglutide injection |
| Vehicle Group | Placebo comparator | Subcutaneous injection of vehicle Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of delirium
Confusion Assessment Method (CAM), or its variant for the Intensive Care Unit, known as CAM-ICU, is the tool used to assess the incidence of delirium. For CAM, the scale ranges from a minimum value of 11 to a maximum of 44, with higher scores indicating a worse outcome. In contrast, CAM-ICU does not utilize a numerical scale; it is a qualitative assessment designed to evaluate confusion without assigning specific values.
Measured: One day before surgery and within the first seven days after surgery.
Secondary outcomes (33)
The severity of delirium
The CAM-Severity Scale (CAM-S), available in both short-form and long-form versions, serves as a tool for assessing the severity of delirium. The scale extends from 0 to 7 in its short-form and from 0 to 19 in its long-form. Higher scores on the CAM-S are indicative of more severe outcomes.
Measured: One day before surgery and within the first seven days after surgery.
Cognitive function
Minimum Mental State Examination (MMSE) is the tool used to assess cognitive function. The scale extends from 0 to 30, with higher scores indicating a better outcome.
Measured: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Anxiety
Generalized anxiety disorder-7 (GAD-7) is the tool used to assess anxiety. The scale extends from 0 to 21, with higher scores indicating a worse outcome.
Measured: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Depression
Patient Health Questionnaire-9 (PHQ-9) is the tool used to assess depression. The scale extends from 0 to 27, with higher scores indicating a worse outcome.
Measured: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Duration of ICU stay
By retrieving the Hospital Information System and ICU special care sheet
Measured: The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.
Mechanical ventilation time
By retrieving the Hospital Information System and ICU special care sheet
Measured: The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.
Duration of hospital stay
By retrieving the Hospital Information System
Measured: The time from hospital admission to discharge, assessed up to 12months.
In-hospital mortality
By retrieving the Hospital Information System
Measured: The time from hospital admission to discharge, assessed up to 12months.
Incidence of adverse events
By retrieving the Hospital Information System, ICU special care sheet and follow-up
Measured: One day preoperatively to three days Postoperatively.
Rate of major cardiovascular adverse events
By retrieving the Hospital Information System, ICU special care sheet and follow-up
Measured: Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)
Serum levels of NSE
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of CRP
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of IL-1α
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of TNF-α
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of C3
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of LDH
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of CK
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of CK-MB
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of AST
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of cTNT
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of BNP
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of C1q
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of IL-1β
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of IL-6
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of S100β
ELISA
Measured: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd)
The echocardiography is used to assess the LVPWTd.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Left Ventricular End-Diastolic Dimension (LVDd)
The echocardiography is used to assess the LVDd.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Left Ventricular End-Systolic Diameter (LVDs)
The echocardiography is used to assess the LVDs.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Left Atrial Diameter (LAD)
The echocardiography is used to assess the LAD.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Ejection Fraction (EF)
The echocardiography is used to assess the EF.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Fractional Shortening (FS)
The echocardiography is used to assess the FS.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Early Diastolic Velocity/Atrial Diastolic Velocity (E/A)
The echocardiography is used to assess the E/A.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Interventricular Septum Thickness in Diastolic (IVSTd)
The echocardiography is used to assess the IVSTd.
Measured: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start19 Nov 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongjin Wang, PhD，MD, Principal investigator, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361238
- Sponsor's protocol ID
- 2023-LCYJ-PY-21
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Application of Liraglutide for the Prevention of Postoperative Delirium Among Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery: a Single-Center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06361238
- Acronym / sponsor ID
- 2023-LCYJ-PY-21
- Conditions
- Delirium, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Apr 2024 (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.
This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery.
Detailed description
Delirium is the most prevalent neurological complication following cardiac surgery. It is characterized by an acute and fluctuating disturbance in consciousness, attention, and cognitive function. The incidence of delirium post-cardiac surgery ranges between 11% and 46%. It is closely linked to increased postoperative mortality, extended hospital stays, higher healthcare costs, and long-term cognitive impairment. Currently, it is widely recognized that the development of delirium is influenced by multiple factors, including advanced age, diabetes, surgical and anesthetic techniques, depression, baseline cognitive function, and infections, among others.
Inflammatory responses, crucial for protecting against external or internal threats, can, following surgery, lead to neuroinflammation and neurological damage due to elevated postoperative inflammatory markers and blood-brain barrier disruption. The involvement of microglia and astrocytes, key players in the central nervous system's immune response, has been identified in mediating postoperative delirium, making them potential targets for prevention.
Liraglutide, a Glucagon-like peptide-1 receptor agonist primarily used for treating Type 2 diabetes, has shown promise in mitigating neurocognitive damage associated with diabetes and Alzheimer's disease, suggesting its potential in preventing postoperative delirium in cardiac surgery patients with Type 2 diabetes. Preliminary animal studies and a randomized controlled trial indicate that perioperative liraglutide application could reduce the incidence of postoperative delirium by inhibiting glial activation and the subsequent neuroinflammatory response. However, differences in patient demographics, disease severity, and dosing in previous studies highlight the need for further investigation.
The study aims to investigate whether the perioperative administration of liraglutide can prevent the onset of postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. Secondary objectives include assessing the impact on the severity and duration of delirium, cognitive function, anxiety, depression, cardiac function, cardiovascular events, ICU stay, mechanical ventilation duration, and levels of serum markers for brain injury, inflammation, myocardial damage, and cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide Group | Experimental | Drug: Liraglutide injectionSubcutaneous injection of liraglutide |
| Vehicle Group | Placebo comparator | Drug: Placebo injectionSubcutaneous injection of vehicle |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 years
- Type 2 diabetes
- Patients undergoing elective cardiac surgery
Key exclusion criteria (14 listed)
- History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc
- Patients with communication difficulties, such as severe visual, auditory, or speech impairments
- History of central nervous system damage or surgery
- Cardiac function NYHA Class IV
- Severe liver dysfunction (Child-Pugh Class C)
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 |
|---|---|---|
| Liraglutide injectionAlso: VictozaSubcutaneous injection of liraglutide: 0.6 mg administered the day before surgery, 1.8 mg administered post-anesthesia induction on the day of surgery, followed by 0.6 mg daily for the first three postoperative days. | Drug | Liraglutide Group |
| Placebo injectionAlso: Normal salineSubcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times. | Drug | Vehicle Group |
Primary outcome
The incidence of delirium
Time frame: One day before surgery and within the first seven days after surgery.
Confusion Assessment Method (CAM), or its variant for the Intensive Care Unit, known as CAM-ICU, is the tool used to assess the incidence of delirium. For CAM, the scale ranges from a minimum value of 11 to a maximum of 44, with higher scores indicating a worse outcome. In contrast, CAM-ICU does not utilize a numerical scale; it is a qualitative assessment designed to evaluate confusion without assigning specific values.
33 secondary outcomes
The severity of delirium
Time frame: One day before surgery and within the first seven days after surgery.
Cognitive function
Time frame: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Anxiety
Time frame: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Depression
Time frame: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Duration of ICU stay
Time frame: The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.
Mechanical ventilation time
Time frame: The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.
Duration of hospital stay
Time frame: The time from hospital admission to discharge, assessed up to 12months.
In-hospital mortality
Time frame: The time from hospital admission to discharge, assessed up to 12months.
Incidence of adverse events
Time frame: One day preoperatively to three days Postoperatively.
Rate of major cardiovascular adverse events
Time frame: Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)
Serum levels of NSE
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of CRP
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of IL-1α
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of TNF-α
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of C3
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of LDH
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of CK
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of CK-MB
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of AST
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of cTNT
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of BNP
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of C1q
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of IL-1β
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of IL-6
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Serum levels of S100β
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Left Ventricular End-Diastolic Dimension (LVDd)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Left Ventricular End-Systolic Diameter (LVDs)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Left Atrial Diameter (LAD)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Ejection Fraction (EF)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Fractional Shortening (FS)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Early Diastolic Velocity/Atrial Diastolic Velocity (E/A)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Interventricular Septum Thickness in Diastolic (IVSTd)
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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.
Dongjin Wang, PhD，MD principal investigator
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide injection in people with Delirium, Postoperative, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 14 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: looking for participants now, as of the sponsor's last update on 20 Dec 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenxue Liu, PhD，MD (15751866806, diligent_hi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of delirium (time frame: One day before surgery and within the first seven days after surgery.). 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 20 Dec 2024.