Clinical trial NCT06825156: Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors
Official title: The Perioperative Renal and Metabolic Outcomes After Sodium Glucose Cotransporter 2 Inhibitor in Cardiac Surgery - an Open-label Phase IV Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: CSA-AKI
SGLT-2i
Cardiac surgery
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NGAL
timeFrame: Day 2 post surgery
Secondary outcomes:
measure: Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.
timeFrame: Before surgery, day of surgery, day 1+2 after surgery
measure: Kidney Injury Molecule-1 (KIM-1) in plasma.
timeFrame: Before surgery, day of surgery, day 1+2 after surgery
measure: Perioperative peak and average blood glucose levels, as measured during usual care.
timeFrame: During study per untill 4 days post-operatively
measure: Blood ketone levels.
timeFrame: During surgery at 4 measurement moments or during usual care.
measure: Renal functioning (KDIGO criteria)
timeFrame: During study period untill post-operative day 4
Other outcomes:
measure: Ketoacidosis
timeFrame: During study period untill post-operative day 4
measure: Hypoglycemia
timeFrame: During study period untill post-operative day 4
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Amsterdam University Medical Centre
state: Noord-Holland
Study officials:
affiliation: Amsterdam University Medical Centre
name: Jeroen Hermanides, Dr.
role: PRINCIPAL_INVESTIGATOR
References: