Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Acute Kidney Injury

Interventions

Empagliflozin 10 MGDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Amsterdam University Medical Centre

Amsterdam-Zuidoost, North Holland, Netherlands

Outcomes

Primary Outcomes

NGAL

Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2

Time frame: Day 2 post surgery

Secondary Outcomes

Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.

NGAL measured in plasma

Time frame: Before surgery, day of surgery, day 1+2 after surgery

Kidney Injury Molecule-1 (KIM-1) in plasma.

KIM-1 concentration measured in plasma

Time frame: Before surgery, day of surgery, day 1+2 after surgery

Perioperative peak and average blood glucose levels, as measured during usual care.

Glucose levels recorded during usual routine care

Time frame: During study per untill 4 days post-operatively

Blood ketone levels.

Blood ketones measured intra-operatively

Time frame: During surgery at 4 measurement moments or during usual care.

Renal functioning (KDIGO criteria)

development of serum creatinine levels and urine output measured untill post-operative day 4

Time frame: During study period untill post-operative day 4

Data from ClinicalTrials.gov

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