Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT06825156
Phase
PHASE4
Status
Completed

Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 3, 2022
Status verified
Feb 2025
Primary completion
May 26, 2023
Completion
May 26, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Controlled (usual care)
    Standard of care, Some additional blood drawn and urine collected to compare between both groups
  • Experimental: Intervention(Medication group)
    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 Measure

NGAL [ Time Frame: Day 2 post surgery ]

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