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CompletedNCT06432751SGLT2i-PO-AKIUpdated May 29, 2024

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

An observational study in Acute Kidney Injury, Cardiac Surgery and Sodium/Glucose Cotransporter Inhibitor 2, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

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

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Keywords

  • Acute Kidney Injury
03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's enrollment of 500 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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What researchers measure

Primary outcomes

  1. Post-operative acute kidney injury

    Serum creatinine increase by 0.3 mg/dl within 48 h

    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

  2. Post-operative acute kidney injury

    Serum creatinine ≥ 1.5-1.9 times baseline within 7 days

    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

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Study locations

1 site
  • Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
    Bron, Rhône 69500, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in Apr 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2024
First posted
May 29, 2024
StartActual
Apr 1, 2024
Primary completionActual
Apr 10, 2024
CompletionActual
May 10, 2024
Last update
May 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06432751
Responsible party
Sponsor
First posted
May 29, 2024
Start date
Apr 1, 2024
Primary completion
Apr 10, 2024
Completion
May 10, 2024
Last update
May 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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