Clinical trial NCT06432751: Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery
Official title: Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Cardiac Surgery
Sodium/Glucose Cotransporter Inhibitor 2
Keywords: Acute Kidney Injury
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1200 patients admitted in the Louis Pradel Hospital for cardiac surgery in the study period

Brief summary: Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis.

In recent years, inhibitors of the sodium/glucose co-transporter type 2 have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease.

Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations.

The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Cardiac surgery with cardiopulmonary bypass
* Presenting a simplified renal risk score ≥ 2 points defined as follows:

  * Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points
  * Diabetes requiring treatment: 1 point
  * LVEF ≤ 40%: 1 point
  * Previous cardiac surgery: 1 point
  * Pre-operative intra-aortic counter pulsation: 1 point
  * Non elective surgery: 1 point
  * Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point

Exclusion Criteria:

* Haemodialysis prior to surgery
* Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m2.
* Death in the operating theatre
* Opposition of the patient to the use of his/her health data

Primary outcomes:
measure: Post-operative acute kidney injury
timeFrame: Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days
measure: Post-operative acute kidney injury
timeFrame: Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
state: Rhône
Study officials:
References: