Using liraglutide to prevent delirium in elderly diabetic patients after heart surgery
Perioperative Application of Liraglutide for the Prevention of Postoperative Delirium Among Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery: a Single-Center Randomized Controlled Study
This study is testing if liraglutide can help prevent confusion after heart surgery in older diabetic patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06361238 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of liraglutide, a medication commonly used for Type 2 diabetes, in preventing postoperative delirium in elderly patients undergoing cardiac surgery. Delirium is a significant complication that can lead to increased mortality and longer hospital stays. The trial will compare the effects of liraglutide injections against placebo injections in this patient population. By targeting neuroinflammation, the study aims to reduce the incidence of delirium and improve postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 and above with Type 2 diabetes who are scheduled for elective cardiac surgery.
Not a fit: Patients with a history of neurological or psychiatric disorders, severe liver dysfunction, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the occurrence of delirium in elderly diabetic patients after cardiac surgery, leading to better recovery and lower healthcare costs.
How similar studies have performed: Preliminary studies have shown promise for similar approaches, but this specific application of liraglutide in preventing postoperative delirium is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Wenxue liu — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Dongjin Wang, PhD，MD — Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
- Study coordinator: Wenxue Liu, PhD，MD
- Email: diligent_hi@163.com
- Phone: 15751866806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.