Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT05454735
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Study Overview
Official Title:
Perioperative Blood Glucose Variability and Autonomic Nervous System Activity in On-pump Cardiac Surgery Patients: Study Protocol of a Single-center Observational Study.
Status:
COMPLETED
Status Verified Date:
2025-01
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:
CAESAR
Brief Summary:
On-pump coronary artery bypass graft (CABG) and valve replacement surgeries are high-risk procedures. Among the risk factors for postoperative complications, perioperative hyperglycemia and blood glucose variability have been reported to be associated with increased morbidity and mortality. The treatment of hyperglycemia using intravenous insulin infusion improves the prognosis in cardiac surgery patients. However, the determinants of postoperative blood glucose variability and the mechanisms leading to its deleterious impact are unknown. Thus, to date, there is no therapeutic intervention that could effectively prevent and treat the deleterious impact of glycemic variability on postoperative outcome. The purpose of the study is to evaluate whether perioperative alteration of the autonomic nervous system and preoperative blood glucose variability could be related to perioperative glycemic variability.
Detailed Description:
The main objective is to describe the relationship between preoperative glycemic variability and glycemic variability during the first 48 postoperative hours.
The secondary objectives are :
1. to describe the relationship between preoperative glycemic variability and glycemic variability during the first 48 hours postoperative according to:
* diabetic and non-diabetic status
* the type of surgical intervention
2. to describe the relationship between the parameters evaluating the preoperative activity of the autonomic nervous system and:
* preoperative glycemic variability
* glycemic variability during the first 48 postoperative hours
3. to describe the relationship between glycemic variability during the first 48 postoperative hours and:
* parameters evaluating the activity of the autonomic nervous system during the first 48 postoperative hours
* diabetes phenotype
* markers of inflammation
* markers of endothelial dysfunction
4. to describe the morbidity and mortality within 30 days after surgery.
The secondary objectives are :
1. to describe the relationship between preoperative glycemic variability and glycemic variability during the first 48 hours postoperative according to:
* diabetic and non-diabetic status
* the type of surgical intervention
2. to describe the relationship between the parameters evaluating the preoperative activity of the autonomic nervous system and:
* preoperative glycemic variability
* glycemic variability during the first 48 postoperative hours
3. to describe the relationship between glycemic variability during the first 48 postoperative hours and:
* parameters evaluating the activity of the autonomic nervous system during the first 48 postoperative hours
* diabetes phenotype
* markers of inflammation
* markers of endothelial dysfunction
4. to describe the morbidity and mortality within 30 days after surgery.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: