Actively Recruiting

Phase 3
Age: 60Years +
All Genders
ID06361238

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

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Diagnosis of Type 2 diabetes
  • Scheduled for elective cardiac surgery
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Post-operative Follow-up

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

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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

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