Actively Recruiting
Perioperative Liraglutide to Prevent Postoperative Delirium in Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery: A Randomized Controlled Study
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-12-20
260
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Delirium is a common neurological complication after cardiac surgery, especially in elderly patients with Type 2 diabetes. It involves sudden changes in consciousness, attention, and thinking, and can lead to higher death rates, longer hospital stays, and lasting cognitive problems. This trial studies whether giving the diabetes medicine liraglutide around the time of surgery can help prevent delirium in these patients. Participants will receive either liraglutide or a placebo through injections. The liraglutide is given as 0.6 mg under the skin the day before surgery, then 1.8 mg after anesthesia starts on surgery day, followed by 0.6 mg daily for three days after surgery. The placebo group receives injections matching the liraglutide schedule. This is a phase 3 randomized controlled study conducted at one center. During the study, researchers will monitor patients for delirium starting one day before surgery and continuing for seven days after. They will also assess the severity and length of delirium, cognitive and emotional function, heart health, time in intensive care, and blood markers related to brain injury, inflammation, and heart damage. The goal is to determine if liraglutide can reduce delirium and improve overall recovery in elderly diabetic patients undergoing heart surgery.
CONDITIONS
Official 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 communication difficulties including visual, auditory, or speech impairments
- History of central nervous system damage or surgery
- Cardiac function classified as NYHA Class IV
- Severe liver dysfunction (Child-Pugh Class C)
- Severe renal failure requiring renal replacement therapy
- History of pancreatitis
- Diagnosis of Type 1 diabetes
- Blood sugar not controlled within 4-8 mmol/L during screening
- Medullary thyroid carcinoma or family history of it
- Pregnant or breastfeeding women
- Allergy or intolerance to liraglutide
- Previous use of GLP-1A or SGLT2i medications
- Refusal to provide informed consent
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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
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