Diagnostic accuracy of urine biomarkers for acute kidney injury after major surgery

Completed

Conditions: acute kidney injury
acute kidney insufficiency
Acute renal failure
acute tubular necrosis
10038430
10017998

Registration Number: NL-OMON42513

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

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

Patients with end-stage renal disease (defined as baseline eGFR *15 mL/min).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the proposed study is to determine which urine<br /><br>biomarkers have sufficient diagnostic accuracy (defined as area under receiver<br /><br>oerating characteristic curve greater than 0.70) for early diagnosis of acute<br /><br>kidney injury (defined as an increase in serum creatinine concentration of more<br /><br>than 26 micromol/L or more than 50% of baseline in the first two postoperative<br /><br>days) in patients undergoing major general surgery. Urine biomarkers to be<br /><br>studied are NGAL, KIM-1 and IL-18; further biomarkers of interest will be<br /><br>identified by systematic review and meta-analysis of the scientific literature. </p><br>

Secondary Outcome Measures