Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

NCT06825156 | Completed Phase 4

• 1 other identifier: NL78156.018.21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

CSA-AKI; SGLT-2i; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• NGAL

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

  Day 2 post surgery

Secondary Outcomes (5)

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

  Before surgery, day of surgery, day 1+2 after surgery

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

  Before surgery, day of surgery, day 1+2 after surgery

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

  During study per untill 4 days post-operatively

• Blood ketone levels.

  During surgery at 4 measurement moments or during usual care.

• Renal functioning (KDIGO criteria)

  During study period untill post-operative day 4

Other Outcomes (2)

• Ketoacidosis

  During study period untill post-operative day 4

• Hypoglycemia

  During study period untill post-operative day 4

Study Arms (2)

Controlled (usual care)

NO INTERVENTION

Standard of care, Some additional blood drawn and urine collected to compare between both groups

Intervention(Medication group)

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MG DRUG

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

Also known as: Gliflozin, SGLT-2i

Intervention(Medication group)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• European Commission: collaborator

Study Sites (1)

Amsterdam University Medical Centre

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

Location

Related Links

• Link of the former published study protocol, National register of the Netherlands has ceased to exist.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

empagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Jeroen Hermanides, Dr.

  Amsterdam University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs.

Model Details: Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: March 3, 2022
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: at least 5 years after publication
• Access Criteria: Relevant reason to validate the request for access of this data

Locations

NL (1)