Relation Between Insulinoresistance and Neutrophile to Lymphocyte Ratio in Cardiac Surgery. (NCT06945536) | Clinical Trial Compass
CompletedNot Applicable
Relation Between Insulinoresistance and Neutrophile to Lymphocyte Ratio in Cardiac Surgery.
France211 participantsStarted 2024-08-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Subject in the exclusion period of another study or provided for by the "national volunteer file"
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensibilty Insuline Index (SII)
Timeframe: 48 hours
Trial details
NCT IDNCT06945536
SponsorCentre Hospitalier Universitaire de Besancon