Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery
NCT ID: NCT06361238
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
260 participants
INTERVENTIONAL
2024-11-19
2028-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Liraglutide Group
Subcutaneous injection of liraglutide
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.
Vehicle Group
Subcutaneous injection of vehicle
Placebo injection
Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Type 2 diabetes
3. Patients undergoing elective cardiac surgery
Exclusion Criteria
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 is difficult to control within 4-8 mmol/L during the screening 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
60 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Principal Investigators
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Dongjin Wang, PhD，MD
Role: PRINCIPAL_INVESTIGATOR
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Locations
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Wenxue liu
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Wenxue NA Liu, MD$PHD
Role: primary
Other Identifiers
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2023-LCYJ-PY-21
Identifier Type: -
Identifier Source: org_study_id