Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361238
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-19
Brief Title:
Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 systems 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 Alzheimers 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
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 systems 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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None