Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery (SGLT2i-PO-AKI)

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Cardiac Surgery; Sodium/Glucose Cotransporter Inhibitor 2
• Intervention / Treatment: Other: Post Operative Acute Kidney Injury

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Rhône
    • Bron, Rhône, France, 69500
      • Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1200 patients admitted in the Louis Pradel Hospital for cardiac surgery in the study period

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; 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.	Other: Post Operative Acute Kidney Injury; Serum creatinine increase by 0.3 mg/dl within 48 h OR Serum creatinine ≥ 1.5-1.9 times baseline within 7 days Baseline creatinine is defined as the last pre-operative value available in the medical file

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative acute kidney injury	Serum creatinine increase by 0.3 mg/dl within 48 h	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
Post-operative acute kidney injury	Serum creatinine ≥ 1.5-1.9 times baseline within 7 days	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Acute Kidney Injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 69HCL24_0517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No