acute kidney injury acute kidney insufficiency Acute renal failure acute tubular necrosis
Conditions
Interventions
The patient will have two extra blood sample collections as intervention.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients of 18 years or older. Patients who undergo elective major general surgery, including the following operations: open aortic reconstruction, major limb amputation [i.e. transfemoral or transtibial amputations, excluding foot amputations], lower limb bypass surgery, colorectal resection, major liver resection [resection of more than one liver segment], pancreatectomy, oesophagectomy and gastrectomy.
Exclusion criteria
Exclusion criteria: Patients with end-stage renal disease (defined as baseline eGFR *15 mL/min).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the proposed study is to determine which urine biomarkers have sufficient diagnostic accuracy (defined as area under receiver oerating characteristic curve greater than 0.70) for early diagnosis of acute kidney injury (defined as an increase in serum creatinine concentration of more than 26 micromol/L or more than 50% of baseline in the first two postoperative days) in patients undergoing major general surgery. Urine biomarkers to be studied are NGAL, KIM-1 and IL-18; further biomarkers of interest will be identified by systematic review and meta-analysis of the scientific literature. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the proposed study are: - To compare the diagnostic accuracy of urine biomarkers for early diagnosis of acute kidney injury. - To determine the optimal cut-off value and corresponding sensitivity and specificity of the urine biomarkers for acute kidney injury. - To evaluate the clinical outcome of patients with discordant findings of urine biomarker tests and conventional serum creatinine tests of acute kidney injury. - To assess whether the diagnostic accuracy of urine biomarkers for early diagnosis of acute kidney injury differs for abdominal surgery and vascular surgery, with the duration of surgery, and with the presence of preoperative risk factors for AKI (diabetes mellitus, chronic kidney disease [eGFR 70 years]). - To determine whether urine biomarkers for acute kidney injury and the KDIGO definition of acute kidney injury are associated with fast renal decline (defined as eGFR reduction of >4 mL/min/year) at one year after surgery. - To study the diagnostic accuracy of creatinine clearance in a 15-minute timed urine collection on arrival at the postoperative recovery unit for early diagnosis of acute kidney injury. | — |
Countries
Netherlands
Outcome results
None listed