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

NCT06432751 | Completed

• 1 other identifier: 69HCL24_0517
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Cardiac Surgery; Sodium/Glucose Cotransporter Inhibitor 2

Keywords

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Post Operative Acute Kidney Injury OTHER

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

Cohort

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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

Bron, Rhône, 69500, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 29, 2024
• Study Start: April 1, 2024
• Primary Completion: April 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)