Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

NCT06361238 | Recruiting Phase 3

• 1 other identifier: 2023-LCYJ-PY-21
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (33)

• The severity of delirium

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

• Cognitive function

  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

  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

  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

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

Study Arms (2)

Liraglutide Group

EXPERIMENTAL

Subcutaneous injection of liraglutide

Drug: Liraglutide injection

Vehicle Group

PLACEBO COMPARATOR

Subcutaneous injection of vehicle

Drug: Placebo injection

Interventions

Liraglutide injection DRUG

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.

Also known as: Victoza

Liraglutide Group

Placebo injection DRUG

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

Also known as: Normal saline

Vehicle Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Wenxue liu

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Liraglutide; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dongjin Wang, PhD，MD

  Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxue Liu, PhD，MD

CONTACT

15751866806; diligent_hi@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 11, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)