Wenxue liu
Nanjing, Jiangsu, 210000, China
Location status: Recruiting
NCT Number: NCT06361238
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 3
Nanjing, Jiangsu, 210000, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Victoza
Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.
Other names: Normal saline
Time frame: 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.
Time frame: One day before surgery and within the first seven days after surgery.
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; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
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.
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.
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.
Time frame: The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.
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.
By retrieving the Hospital Information System and ICU special care sheet
Time frame: The time from hospital admission to discharge, assessed up to 12months.
By retrieving the Hospital Information System
Time frame: The time from hospital admission to discharge, assessed up to 12months.
By retrieving the Hospital Information System
Time frame: One day preoperatively to three days Postoperatively.
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)
By retrieving the Hospital Information System, ICU special care sheet and follow-up
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively
ELISA
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the LVPWTd.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the LVDd.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the LVDs.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the LAD.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the EF.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the FS.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the E/A.
Time frame: One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
The echocardiography is used to assess the IVSTd.
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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