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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06453161
Acronym
SGLT2i
Enrollment
500
Registered
2024-06-11
Start date
2024-04-01
Completion date
2024-05-10
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Cardiac, Surgery

Keywords

Acute kidney injury, Cardiac surgery, Sodium/glucose cotransporter inhibitor 2

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 (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.

Interventions

OTHERPost-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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative acute kidney injuryBaseline 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 daysSerum 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026