Acute Kidney Injury
Conditions
Keywords
protein load, cardiac surgery
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.
Interventions
None listed
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Shanghai Jiao Tong University School of Medicine
Robert Bosch Medical Center
Ospedale San Bortolo di Vicenza
Azienda Ospedaliero Universitaria Maggiore della Carita
Charite University, Berlin, Germany
University of Giessen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Preoperative | Renal functional reserve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To analyze an acute kidney injury risk prediction model based on clinical covariates. | Preoperative | Renal functional reserve |
| Mortality at 30 and 90 days | 30 and 90 days after surgery | Mortality |
| Length of stay in intensive care unit and hospital. | Postoperative | Hospital stay |
| Use and duration of renal replacement therapy during hospital stay. | Postoperative | Renal replacement therapy |
| determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury. | Preoperative | Renal functional reserve |
| To evaluate renal function at three months after surgery. | 3 months after surgery | Estimated glomerular filtration rate |
| To evaluate whether preoperative RFR is correlated to renal function at three months after surgery. | Preoperative | Renal functional reserve |
| To evaluate whether chronic kidney disease is associated to preoperative RFR. | Preoperative | Renal functional reserve |
| Renal replacement therapy dependence at days 30 and 90. | 30 and 90 days after surgery | Renal replacement therapy |
Countries
Germany
Outcome results
None listed