Relation Between Insulinoresistance and Neutrophile to Lymphocyte Ratio in Cardiac Surgery.

NCT06945536 | Completed

• 1 other identifier: 2024/896
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

The University Hospital of Besançon is conducting a public interest research project called CRYSTAL, who studies the relationship between the Neutrophil to Lymphocyte ratio (NLR) and insulin resistance in post-operative cardiac surgery. This study could make it possible to determine, thanks to an easily measurable marker in the blood upon leaving the cardiac surgery operating room, which patients are at risk of developing insulin resistance and who would deserve close monitoring of glycemia following cardiac surgery. Coronary artery bypass graft (CABG) and valve replacement surgeries under extracorporeal circulation (ECB) are considered high-risk procedures, particularly due to the inflammation generated by ECB. This inflammation is the cause of metabolic disturbances including insulin resistance, which causes stress hyperglycemia and glycemic variability that alters the prognosis. Insulin treatment is effective but requires enhanced monitoring and intensive care. Beyond discharge from intensive care, some patients still have insulin resistance that can persist for several days, and whose management cannot be optimally carried out in a conventional hospitalization department. The persistence of insulin resistance is explained by the intensity of the postoperative inflammatory reaction. The NLR is a simple and reliable indicator to quantify this inflammation. The hypothesis of this study is therefore that the NLR could predict the onset of prolonged postoperative insulin resistance and identify patients likely to benefit from enhanced glycemic monitoring.

Conditions

Insulin Resistance; Cardiac Surgery Requiring Cardiopulmonary Bypass; Neutrophil Lymphocyte Ratio

Keywords

post operative cardiac surgery; neutrophil and lymphocyte ratio; insulin resistance

Outcome Measures

Primary Outcomes (1)

• Sensibilty Insuline Index (SII)

  SII = Average glycemia over 24 hours (mmol/L)/Total insulin dose over 24 hours (IU/L)

  48 hours

Secondary Outcomes (1)

• Insulin Dose-Response Index (IDRI)

  48 hours

Study Arms (1)

Adult patients undergoing planned on-pump and off-pump cardiac surgery

Adult patients aged \> 18 years undergoing planned coronary artery bypass surgery, surgical valve replacement, aortic surgery and surgery combining the listed procedures.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had a cardiac surgery in CHU of Besançon

You may qualify if:

• Men and women aged over 18
• Scheduled cardiac surgery
• Blood count the day of admission to the IS
• Subject not objecting to the use of their personal data and/or biological samples
• Affiliation to a French social security scheme or beneficiary of such a scheme

You may not qualify if:

• Immunosuppressive treatment
• Pre-existing corticosteroid therapy
• Hematological pathologies
• Current infection (current antibiotic therapy)
• Active tumor disease
• End-stage renal failure (DFG \< 30 ml/min/1.73m² or on dialysis)
• Severe liver failure (TP \< 50%)
• Diabetics on insulin
• Admission to a care unit other than Thoracic and Cardiovascular Surgery Intensive Care (SI CTCV) in the immediate post-operative period
• Pregnant women, parturients and breastfeeding mothers
• Persons deprived of their liberty by a judicial or administrative decision; persons subject to psychiatric care under constraint; persons admitted to a health or social establishment for purposes other than research
• Minors
• Adults subject to a legal protection measure or unable to express their consent
• Subject without health insurance

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: April 25, 2025
• Study Start: August 25, 2024
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: April 25, 2025

Record last verified: 2024-08

Locations

FR (1)