Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-03-01
2023-01-21
Brief Summary
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Detailed Description
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The investigators seek to determine whether a reduced preoperative RFR predicts postoperative AKI in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. All centres will measure RFR with creatinine clearance, except University Hospital Giessen where in addition iohexol plasma-clearance will be used.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
3. Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
4. Subjects who signed informed consent forms
Exclusion Criteria
2. Chronic kidney disease ≥ stage III (KDIGO)
3. Subjects undergoing transcatheter aortic valve implantation (TAVI)
4. Pregnancy
5. Solitary kidney
6. Diabetes mellitus type 1
7. Recent cardiac arrest (within last 3 months)
8. Liver failure or cirrhosis
9. Total parenteral nutrition
10. Hemoglobin \<11 g/dl
11. Sepsis
12. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
13. Transplant donor or recipient
14. Active autoimmune disease with renal involvement
15. Rhabdomyolysis
16. Prostate hypertrophy with International Prostate Symptom Score ≥20
17. Active neoplasm
18. Decompensated heart failure / inability to pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load
21. Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load
22. Subjects who received NSAIDs within 48 hours before the protein load
18 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Robert Bosch Medical Center
OTHER
Ospedale San Bortolo di Vicenza
OTHER
Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Charite University, Berlin, Germany
OTHER
University of Giessen
OTHER
Responsible Party
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Faeq Husain-Syed
Senior Physician
Principal Investigators
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Claudio Ronco, MD
Role: STUDY_DIRECTOR
San Bortolo Hospital, Vicenza, Italy
Locations
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University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, Germany
Countries
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References
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Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.
Sharma A, Zaragoza JJ, Villa G, Ribeiro LC, Lu R, Sartori M, Faggiana E, de Cal M, Virzi GM, Corradi V, Brocca A, Husain-Syed F, Brendolan A, Ronco C. Optimizing a kidney stress test to evaluate renal functional reserve. Clin Nephrol. 2016 Jul;86(7):18-26. doi: 10.5414/CN108497.
Ronco C, Kellum JA, Haase M. Subclinical AKI is still AKI. Crit Care. 2012 Jun 21;16(3):313. doi: 10.1186/cc11240.
Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery. Nephrol Dial Transplant. 2019 Feb 1;34(2):308-317. doi: 10.1093/ndt/gfy227.
Other Identifiers
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AZ 216/17
Identifier Type: -
Identifier Source: org_study_id
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