Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery

Completed

• Conditions: Acute Kidney Injury; Sodium/Glucose Cotransporter Inhibitor 2; Cardiac Surgery
• Interventions: Other: Post Operative Acute Kidney Injury

• Registration Number: NCT06432751
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-04-10
• Status Verified: 2024-05
• Study Completion: 2024-05-10
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Post Operative Acute Kidney Injury	Adults patients with pre-operative simplified predictive risk index for renal replacement therapy after cardiac surgery ≥2, with cardiac surgery performed in Louis Pradel Hospital between 08/2022 and 02/2024.

Primary Outcome Measures

Name	Time	Method
Post-operative acute kidney injury	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	Serum creatinine ≥ 1.5-1.9 times baseline within 7 days

Trial Locations

Locations (1)

Hôpital cardiologique Louis Pradel Groupe Hospitalier Est; 🇫🇷 Bron, Rhône, France