Last updated: January 21, 2023
Sponsor: University of Giessen
Overall Status: Completed
Phase
N/A
Condition
Kidney Failure
Renal Failure
Kidney Disease
Treatment
N/AClinical Study ID
NCT03457987
AZ 216/17
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects older than 18 years
- Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
- Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaborationequation)
- Subjects who signed informed consent forms
Exclusion
Exclusion Criteria:
- Preexisting acute kidney injury (as determined by all available serum creatininevalues from hospital and outpatient medical records within the previous 90 days)
- Chronic kidney disease ≥ stage III (KDIGO)
- Subjects undergoing transcatheter aortic valve implantation (TAVI)
- Pregnancy
- Solitary kidney
- Diabetes mellitus type 1
- Recent cardiac arrest (within last 3 months)
- Liver failure or cirrhosis
- Total parenteral nutrition
- Hemoglobin <11 g/dl
- Sepsis
- History of malabsorption, chronic inflammatory bowel disease, short bowel, orpancreatic insufficiency
- Transplant donor or recipient
- Active autoimmune disease with renal involvement
- Rhabdomyolysis
- Prostate hypertrophy with International Prostate Symptom Score ≥20
- Active neoplasm
- Decompensated heart failure / inability to pause angiotensin-converting enzymeinhibitors or angiotensin II receptor blockers minimum 2 days before protein load
- Known iodine allergy (exclusion criteria only for those centres who use iohexol plasmaclearance for determination of GFR)
- TSH <0.3 µU/l (exclusion criteria only for those centres who use iohexol)
- Subjects who received intravenous radiocontrast agents within the 72 hours before theprotein load
- Subjects who received NSAIDs within 48 hours before the protein load
Study Design
Total Participants: 30
Study Start date:
March 01, 2018
Estimated Completion Date:
January 21, 2023
Study Description
Connect with a study center
University Clinic Giessen and Marburg - Campus Giessen
Gießen, Hessen 35392
GermanySite Not Available

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