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Recruiting NCT06361238

Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

Phase III Interventional Delirium, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liraglutide injection, Placebo injection.
Who it may be relevant to
Registry conditions: Delirium, Postoperative. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • The incidence of delirium [Time frame: One day before surgery and within the first seven days after surgery.]
Secondary outcome measures (12)
  • The severity of delirium [Time frame: One day before surgery and within the first seven days after surgery.]
  • Cognitive function [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 [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 [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 [Time frame: The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.]
  • Mechanical ventilation time [Time frame: The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.]
  • Duration of hospital stay [Time frame: The time from hospital admission to discharge, assessed up to 12months.]
  • In-hospital mortality [Time frame: The time from hospital admission to discharge, assessed up to 12months.]
  • Incidence of adverse events [Time frame: One day preoperatively to three days Postoperatively.]
  • Rate of major cardiovascular adverse events [Time frame: Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)]
  • Serum levels of NSE [Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively]
  • Serum levels of CRP [Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively]

Eligibility criteria

Inclusion criteria

  • Age ≥ 60 years
  • Type 2 diabetes
  • Patients undergoing elective cardiac surgery

Exclusion criteria

  • History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc
  • Patients with communication difficulties, such as severe visual, auditory, or speech impairments
  • History of central nervous system damage or surgery
  • Cardiac function NYHA Class IV
  • Severe liver dysfunction (Child-Pugh Class C)
  • Severe renal failure requiring renal replacement therapy
  • History of pancreatitis
  • Type 1 diabetes
  • Patients whose blood sugar is difficult to control within 4-8 mmol/L during the screening period
  • Patients with medullary thyroid carcinoma or a family history of it
  • Pregnant or breastfeeding women
  • Intolerance or allergy to liraglutide
  • Previous use of GLP-1A and SGLT2i
  • Patients who refuse to sign the informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Wenxue liu — Nanjing

Identifiers

NCT: NCT06361238 · 2023-LCYJ-PY-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗