Preoperative sodium glucose cotransporter 2 inhibitors for prevention of postoperative acute kidney injury in cardiac surgery patients - a randomized, placebo-controlled, multi-centre, phase IV clinical trial
- Conditions
- Cardiac Surgery-Associated Acute Kidney InjuryKidney failure following cardiac surgery10038430
- Registration Number
- NL-OMON53593
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 784
1. >18 years old 2. Undergoing elective cardiac surgery. 3. Providing informed
consent
1. Current treatment with SGLT2 inhibitors 2. Reduced kidney function at
baseline with eGFR < 20 ml/min at time of inclusion 3. Diabetes Mellitus Type 1
4. History of diabetic keto acidosis 5. Diabetes Mellitus Type 2 with BMI<25
for people with type 2 diabetes who are using multiple daily insulin injections
(both short and long-acting insulin) 6. Systolic blood pressure < 100 mmHg at
time of inclusion 7. Emergency surgery, defined as in need of surgery for
medical reasons < 7 days, i.e. *S1-4* according to the Amsterdam UMC
classification 8. Female of child-bearing potential who is pregnant,
breast-feeding or intend to become pregnant or is not using adequate
contraceptive methods 9. 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>Incidence of AKI occurring in 7 days after surgery, according to KDIGO<br /><br>criteria, defined as an increase in serum creatinine by 0.3 mg/dl (26.5 mmol/l)<br /><br>within 48 hours; or an increase in serum creatinine to 1.5 times baseline,<br /><br>within 7 days; or a urine output <0.5 ml/kg/h for >6 hours.</p><br>
- Secondary Outcome Measures
Name Time Method