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

Acute Kidney Injury Clinical Trial

— SGLT2i-PO-AKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06432751
• Other study ID #: 69HCL24_0517
• Status: Completed
• Start date: April 1, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Hôpital cardiologique Louis Pradel Groupe Hospitalier Est	Bron	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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