Clinical trial NCT03457987: Acute Kidney Injury After Cardiac Surgery
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: protein load
cardiac surgery
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Shanghai Jiao Tong University School of Medicine
name: Robert Bosch Medical Center
name: Ospedale San Bortolo di Vicenza
name: Azienda Ospedaliero Universitaria Maggiore della Carita
name: Charite University, Berlin, Germany
First posted: 2018-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults undergoing elective cardiac surgery (with or without cardiopulmonary bypass) with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)

Brief summary: The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects older than 18 years
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:

1. Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
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
19. Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance for determination of GFR)
20. TSH \<0.3 µU/l (exclusion criteria only for those centres who use iohexol)
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

Primary outcomes:
measure: 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.
timeFrame: Preoperative
Secondary outcomes:
measure: determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.
timeFrame: Preoperative
measure: To analyze an acute kidney injury risk prediction model based on clinical covariates.
timeFrame: Preoperative
measure: Mortality at 30 and 90 days
timeFrame: 30 and 90 days after surgery
measure: Length of stay in intensive care unit and hospital.
timeFrame: Postoperative
measure: Use and duration of renal replacement therapy during hospital stay.
timeFrame: Postoperative
measure: Renal replacement therapy dependence at days 30 and 90.
timeFrame: 30 and 90 days after surgery
measure: To evaluate renal function at three months after surgery.
timeFrame: 3 months after surgery
measure: To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.
timeFrame: Preoperative
measure: To evaluate whether chronic kidney disease is associated to preoperative RFR.
timeFrame: Preoperative
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University Clinic Giessen and Marburg - Campus Giessen
state: Hessen
Study officials:
affiliation: San Bortolo Hospital, Vicenza, Italy
name: Claudio Ronco, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Ronco C, Kellum JA, Haase M. Subclinical AKI is still AKI. Crit Care. 2012 Jun 21;16(3):313. doi: 10.1186/cc11240.
citation: 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.