Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Empagliflozin 10 MG

• Registration Number: NCT06825156
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

To investigate the potential of preoperative initiation (3 days) and perioperative continuation (until day 2 after surgery) of empagliflozin(sodium glucose co transporter 2 inhibitor(SGLT-2i)) 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (NGAL) measured in serum and urine on day 2 postoperatively in patients undergoing cardiopulmonary bypass surgery by comparing a study medication group to a control group in an open-label set-up.

Detailed Description

Adult patients scheduled for elective cardiopulmonary bypass assisted cardiothoracic surgery will be informed about the study and after receiving informed consent will be divided between two groups in an openlabel fashion:

Intevention group: Takes study medication(10mg Empagliflozin once a day in the morning) 3 days prior to surgery, day of surgery and 2 days post-surgery.

Control group: follows the usual standard of care. At time moment before surgery and before medication is taken blood and urine sample is taken. This is repeated on day of surgery, and the consecutive 2 days after surgery.

Form these samples biomakers for kidney injury will be measured and compared between groups.

Study Timeline

• Study Start: 2022-03-03
• Primary Completion: 2023-05-26
• Study Completion: 2023-05-26
• Status Verified: 2025-02
• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 to 90 years old (inclusive)
• Undergoing elective cardiac surgery with cardio-pulmonary bypass.
• Providing informed consent

Exclusion Criteria

Current treatment with SGLT2 inhibitors.

• Diabetes Mellitus Type 1
• BMI<25 for people with type 2 diabetes
• Reduced renal function at baseline with eGFR < 30 ml/min.
• Systolic blood pressure < 100 mmHg at time of inclusion.
• Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. "S1-4" according to the Amsterdam UMC classification.
• Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
• Known or suspected allergy to trial products or other drugs in the same class.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention(Medication group)	Empagliflozin 10 MG	Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.

Primary Outcome Measures

Name	Time	Method
NGAL	Day 2 post surgery	Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2

Secondary Outcome Measures

Name	Time	Method
Kidney Injury Molecule-1 (KIM-1) in plasma.	Before surgery, day of surgery, day 1+2 after surgery	KIM-1 concentration measured in plasma
Blood ketone levels.	During surgery at 4 measurement moments or during usual care.	Blood ketones measured intra-operatively
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.	Before surgery, day of surgery, day 1+2 after surgery	NGAL measured in plasma
Perioperative peak and average blood glucose levels, as measured during usual care.	During study per untill 4 days post-operatively	Glucose levels recorded during usual routine care
Renal functioning (KDIGO criteria)	During study period untill post-operative day 4	development of serum creatinine levels and urine output measured untill post-operative day 4

Trial Locations

Locations (1)

Amsterdam University Medical Centre; 🇳🇱 Amsterdam-Zuidoost, Noord-Holland, Netherlands