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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06361238
Other study ID # 2023-LCYJ-PY-21
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 30, 2024
Est. completion date March 31, 2027

Study information

Verified date March 2024
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Wenxue Liu, PhD,MD
Phone 15751866806
Email diligent_hi@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 260
Est. completion date March 31, 2027
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Age = 60 years 2. Type 2 diabetes 3. Patients undergoing elective cardiac surgery Exclusion Criteria: 1. History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc 2. Patients with communication difficulties, such as severe visual, auditory, or speech impairments 3. History of central nervous system damage or surgery 4. Cardiac function NYHA Class IV 5. Severe liver dysfunction (Child-Pugh Class C) 6. Severe renal failure requiring renal replacement therapy 7. History of pancreatitis 8. Type 1 diabetes 9. Patients whose blood sugar cannot be controlled within 4-8 mmol/L during the intervention period 10. Patients with medullary thyroid carcinoma or a family history of it 11. Pregnant or breastfeeding women 12. Intolerance or allergy to liraglutide 13. Previous use of GLP-1A and SGLT2i 14. Patients who refuse to sign the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Liraglutide injection
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 injection
Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One day before surgery and within the first seven days after surgery.
Secondary 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. One day before surgery and within the first seven days after surgery.
Secondary 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. One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary 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. One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary 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. One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Duration of ICU stay By retrieving the Hospital Information System and ICU special care sheet The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.
Secondary Mechanical ventilation time By retrieving the Hospital Information System and ICU special care sheet The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.
Secondary Duration of hospital stay By retrieving the Hospital Information System The time from hospital admission to discharge, assessed up to 12months.
Secondary In-hospital mortality By retrieving the Hospital Information System The time from hospital admission to discharge, assessed up to 12months.
Secondary Incidence of adverse events By retrieving the Hospital Information System, ICU special care sheet and follow-up One day preoperatively to three days Postoperatively.
Secondary Rate of major cardiovascular adverse events By retrieving the Hospital Information System, ICU special care sheet and follow-up Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)
Secondary Serum levels of NSE ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of CRP ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of IL-1a ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of TNF-a ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of C3 ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of LDH ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of CK ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of CK-MB ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of AST ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of cTNT ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of BNP ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of C1q ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of IL-1ß ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of IL-6 ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Serum levels of S100ß ELISA One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
Secondary Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd) The echocardiography is used to assess the LVPWTd. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Left Ventricular End-Diastolic Dimension (LVDd) The echocardiography is used to assess the LVDd. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Left Ventricular End-Systolic Diameter (LVDs) The echocardiography is used to assess the LVDs. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Left Atrial Diameter (LAD) The echocardiography is used to assess the LAD. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Ejection Fraction (EF) The echocardiography is used to assess the EF. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Fractional Shortening (FS) The echocardiography is used to assess the FS. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Early Diastolic Velocity/Atrial Diastolic Velocity (E/A) The echocardiography is used to assess the E/A. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
Secondary Interventricular Septum Thickness in Diastolic (IVSTd) The echocardiography is used to assess the IVSTd. One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
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