- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457987
Acute Kidney Injury After Cardiac Surgery
Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery: The IRRIV Task Force and Collaborators for the Prevention of Acute Kidney Injury
Study Overview
Status
Conditions
Detailed Description
Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiological stress and may serve as a functional marker that assesses susceptibility to injury.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hessen
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Gießen, Hessen, Germany, 35392
- University Clinic Giessen and Marburg - Campus Giessen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Collaboration equation)
- Subjects who signed informed consent forms
Exclusion Criteria:
- Preexisting acute kidney injury (as determined by all available serum creatinine values 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, or pancreatic 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 enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load
- Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance 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 the protein load
- Subjects who received NSAIDs within 48 hours before the protein load
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.
Time Frame: Preoperative
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Renal functional reserve
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Preoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.
Time Frame: Preoperative
|
Renal functional reserve
|
Preoperative
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To analyze an acute kidney injury risk prediction model based on clinical covariates.
Time Frame: Preoperative
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Renal functional reserve
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Preoperative
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Mortality at 30 and 90 days
Time Frame: 30 and 90 days after surgery
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Mortality
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30 and 90 days after surgery
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Length of stay in intensive care unit and hospital.
Time Frame: Postoperative
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Hospital stay
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Postoperative
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Use and duration of renal replacement therapy during hospital stay.
Time Frame: Postoperative
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Renal replacement therapy
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Postoperative
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Renal replacement therapy dependence at days 30 and 90.
Time Frame: 30 and 90 days after surgery
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Renal replacement therapy
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30 and 90 days after surgery
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To evaluate renal function at three months after surgery.
Time Frame: 3 months after surgery
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Estimated glomerular filtration rate
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3 months after surgery
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To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.
Time Frame: Preoperative
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Renal functional reserve
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Preoperative
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To evaluate whether chronic kidney disease is associated to preoperative RFR.
Time Frame: Preoperative
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Renal functional reserve
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Preoperative
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Claudio Ronco, MD, San Bortolo Hospital, Vicenza, Italy
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZ 216/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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