Study of the effects of sodium-glucose cotransporter 2 inhibitors on kidney function and metabolism in patients that undergo cardiac surgery.

Phase 1

• Conditions: Cardiac surgery-associated acute kidney injury; MedDRA version: 20.1Level: LLTClassification code 10080266Term: Stage 1 acute kidney injurySystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2021-003172-13-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-02
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•18 to 90 years old (inclusive)
•Undergoing elective cardiac surgery with cardio-pulmonary bypass.
•Providing informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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 clinical trial of medicinal product
• Study Design: Not specified