Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

Phase 3RecruitingNCT06361238

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School260 enrolled

Overview

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.

Delirium is the most prevalent neurological complication following cardiac surgery. It is characterized by an acute and fluctuating disturbance in consciousness, attention, and cognitive function. The incidence of delirium post-cardiac surgery ranges between 11% and 46%. It is closely linked to increased postoperative mortality, extended hospital stays, higher healthcare costs, and long-term cognitive impairment. Currently, it is widely recognized that the development of delirium is influenced by multiple factors, including advanced age, diabetes, surgical and anesthetic techniques, depression, baseline cognitive function, and infections, among others. Inflammatory responses, crucial for protecting against external or internal threats, can, following surgery, lead to neuroinflammation and neurological damage due to elevated postoperative inflammatory markers and blood-brain barrier disruption. The involvement of microglia and astrocytes, key players in the central nervous system's immune response, has been identified in mediating postoperative delirium, making them potential targets for prevention. Liraglutide, a Glucagon-like peptide-1 receptor agonist primarily used for treating Type 2 diabetes, has shown promise in mitigating neurocognitive damage associated with diabetes and Alzheimer's disease, suggesting its potential in preventing postoperative delirium in cardiac surgery patients with Type 2 diabetes. Preliminary animal studies and a randomized controlled trial indicate that perioperative liraglutide application could reduce the incidence of postoperative delirium by inhibiting glial activation and the subsequent neuroinflammatory response. However, differences in patient demographics, disease severity, and dosing in previous studies highlight the need for further investigation. The study aims to investigate whether the perioperative administration of liraglutide can prevent the onset of postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. Secondary objectives include assessing the impact on the severity and duration of delirium, cognitive function, anxiety, depression, cardiac function, cardiovascular events, ICU stay, mechanical ventilation duration, and levels of serum markers for brain injury, inflammation, myocardial damage, and cardiac function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

260

Conditions

Delirium, Postoperative

Interventions

Liraglutide injectionDRUG

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 injectionDRUG

Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Wenxue liu

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

The incidence of delirium

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.

Time frame: One day before surgery and within the first seven days after surgery.

Secondary Outcomes

The severity of delirium

The CAM-Severity Scale (CAM-S), available in both short-form and long-form versions, serves as a tool for assessing the severity of delirium. The scale extends from 0 to 7 in its short-form and from 0 to 19 in its long-form. Higher scores on the CAM-S are indicative of more severe outcomes.

Time frame: One day before surgery and within the first seven days after surgery.

Cognitive function

Minimum Mental State Examination (MMSE) is the tool used to assess cognitive function. The scale extends from 0 to 30, with higher scores indicating a better outcome.

Time frame: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

Anxiety

Generalized anxiety disorder-7 (GAD-7) is the tool used to assess anxiety. The scale extends from 0 to 21, with higher scores indicating a worse outcome.

Time frame: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

Depression

Patient Health Questionnaire-9 (PHQ-9) is the tool used to assess depression. The scale extends from 0 to 27, with higher scores indicating a worse outcome.

Central Contacts

Wenxue Liu, PhD，MD

CONTACT

15751866806 diligent_hi@163.com

Data from ClinicalTrials.gov

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Time frame: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

Duration of ICU stay

By retrieving the Hospital Information System and ICU special care sheet

Time frame: The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.

Mechanical ventilation time

By retrieving the Hospital Information System and ICU special care sheet

Time frame: The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.

Duration of hospital stay

By retrieving the Hospital Information System

Time frame: The time from hospital admission to discharge, assessed up to 12months.

In-hospital mortality

By retrieving the Hospital Information System

Time frame: The time from hospital admission to discharge, assessed up to 12months.

Incidence of adverse events

By retrieving the Hospital Information System, ICU special care sheet and follow-up

Time frame: One day preoperatively to three days Postoperatively.

Rate of major cardiovascular adverse events

By retrieving the Hospital Information System, ICU special care sheet and follow-up

Time frame: Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)

Serum levels of NSE

ELISA