Glycemic Variability & Autonomic Nervous System in Cardiac Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05454735
Study type	Observational
Source	Centre Hospitalier Universitaire de Besancon
Contact	Etienne CHAZAL, MD
Phone	0630244341
Email	etienne.chazal@gmail.com
Status	Recruiting
Phase
Start date	October 10, 2022
Completion date	December 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients — CAESAR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms