The perioperative renal and metabolic outcomes after sodium-glucose cotransporter-2 inhibitor in cardiac surgery - an open-label phase IV randomized controlled trial
Phase 4
Recruiting
- Conditions
- acute kidney injuryacute renal failurecardiac surgery-associated kidney injury10038430
- Registration Number
- NL-OMON52118
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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
- Not specified
- Primary Outcome Measures
Name Time Method <p>Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma,<br /><br>measured on the morning of postoperative day 2, between 8:00 and 12:00.</p><br>
- Secondary Outcome Measures
Name Time Method