Actively Recruiting
Perioperative Liraglutide to Prevent Postoperative Delirium in Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-12-20
260
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using liraglutide around the time of surgery can prevent postoperative delirium in elderly patients aged 60 and above with Type 2 diabetes undergoing cardiac surgery. Delirium is a common and serious complication after such surgeries, linked to worse outcomes including longer hospital stays and lasting cognitive issues. The study is a randomized controlled trial aimed at understanding if liraglutide can reduce this risk by reducing neuroinflammation. Participants will receive either liraglutide or a placebo through subcutaneous injections. The liraglutide dosing starts with 0.6 mg the day before surgery, followed by 1.8 mg after anesthesia induction on the surgery day, then 0.6 mg daily for the next three days. The placebo group receives injections matching the liraglutide schedule. This treatment is given during the perioperative period in a double-blind setup to assess effects on delirium prevention and other health outcomes. During the study, patients will be closely monitored from one day before surgery through seven days post-surgery for delirium incidence and severity. Cognitive function, anxiety, depression, heart function, ICU stay length, mechanical ventilation time, and hospital stay duration will be assessed at multiple points up to one year after surgery. Blood samples will be taken at set intervals to measure markers related to brain injury, inflammation, and cardiac function. Safety and adverse events will also be tracked throughout the study period.
CONDITIONS
Brief Title
Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Diagnosis of Type 2 diabetes
- Scheduled for elective cardiac surgery
You will not qualify if you...
- History of neurological or psychiatric disorders such as schizophrenia, epilepsy, Parkinson's disease, or severe dementia
- Severe visual, hearing, or speech impairments affecting communication
- History of central nervous system injury or surgery
- Cardiac function classified as NYHA Class IV
- Severe liver dysfunction (Child-Pugh Class C)
- Severe kidney failure requiring dialysis
- History of pancreatitis
- Diagnosis of Type 1 diabetes
- Uncontrolled blood sugar levels outside 4-8 mmol/L during screening
- Medullary thyroid carcinoma or family history of this cancer
- Pregnant or breastfeeding women
- Allergy or intolerance to liraglutide
- Previous use of GLP-1 receptor agonists or SGLT2 inhibitors
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 1 day before surgery to 3 days postoperatively
Participants receive subcutaneous injections of liraglutide or placebo perioperatively, starting the day before surgery, continuing during surgery, and for the first three days after surgery.
1 preoperative visit (in-person), daily visits for 4 days including day of surgery
Duration - Up to 12 months post-surgery
Participants are monitored for delirium, cognitive function, anxiety, depression, cardiac function, cardiovascular events, and serum biomarkers up to 1 year after surgery.
Multiple visits including assessments at 1 week or discharge, 3 months, 6 months, and 1 year postoperatively
Trial Site Locations
Total: 1 location
1
Wenxue liu
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wenxue Liu, PhD,MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here