Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery: a Retrospective Monocentric Cohort Study

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 (1).

In recent years, inhibitors of the sodium/glucose co-transporter type 2 (SGLT2i) 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.

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Key information

Conditions

Acute Kidney Injury Cardiac Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Surgery Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

Bron, Rhône, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Post-operative acute kidney injury

Time frame: 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 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SGLT2i

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 11, 2024
Registry last updated: Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed