NL-OMON26563
Not yet recruiting
Not Applicable
The perioperative renal and metabolic outcomes after sodium glucose cotransporter 2 inhibitor in cardiac surgery – an open-label phase IV randomized controlled trial
Amsterdam UMC location AMC0 sites80 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac surgery associated acute kidney injury
- Sponsor
- Amsterdam UMC location AMC
- Enrollment
- 80
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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