Study of the effects of sodium-glucose cotransporter 2 inhibitors on kidney function in patients undergoing 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: EUCTR2022-002453-25-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-14
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 784

Inclusion Criteria

1. > 18 years old
2. Undergoing elective cardiac surgery.
3. 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 392
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 392

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified