## Protocol Section
### Identification Module
**NCT ID:** NCT06432751

**Acronym:** SGLT2i-PO-AKI

**Brief Title:** Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery

**Official Title:** Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery

#### Organization Study ID Info
**ID:** 69HCL24_0517
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-05-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-10

**Type:** ACTUAL

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Acute Kidney Injury

- Cardiac Surgery

- Sodium/Glucose Cotransporter Inhibitor 2

**Keywords:**

- Acute Kidney Injury

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Post Operative Acute Kidney Injury

**Label:** Cohort

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort

**Description:** 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

**Name:** Post Operative Acute Kidney Injury

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Serum creatinine increase by 0.3 mg/dl within 48 h

**Measure:** 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

**Description:** Serum creatinine ≥ 1.5-1.9 times baseline within 7 days

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 1200 patients admitted in the Louis Pradel Hospital for cardiac surgery in the study period

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bron

**Country:** France

**Facility:** Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

**State:** Rhône

**Zip:** 69500

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Failure

- ID: M28998

- Name: Acute Kidney Injury

- Relevance: HIGH

- As Found: Acute Kidney Injury

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058186

- Term: Acute Kidney Injury

- ID: D000051437

- Term: Renal Insufficiency

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1691

- Name: Sodium-Glucose Transporter 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
