Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

NCT06361238 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Phase

Phase 3

Started

2024-11-19

Last updated

2024-12-20

Condition(s) studied

Delirium, Postoperative

Investigational drug(s) / intervention(s)

Liraglutide injection →Placebo injection

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.

Study 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.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

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 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

Primary outcome measure(s)

The incidence of delirium — One day before surgery and within the first seven days after surgery.
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.

Trial sites (1)

Facility	City	Region	Status
Wenxue liu	Nanjing	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06361238 on ClinicalTrials.gov ↗ ← All trials in China