Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients

Phase 4

Terminated

• Conditions: Obesity; Arterial Hypertension; Hypercholesterolemia; Chronic Liver Disease; Acute Kidney Injury; Cardio Vascular Disease; Diabetes Mellitus
• Interventions: Device: Nephro Check Test; Other: serum creatinine measurement

• Registration Number: NCT02499185
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

To validate the use of \[TIMP-2\]●\[IGFBP-7\] to predict AKI in patients undergoing major intra abdominal surgery.

Detailed Description

A prospective pilot single center study to investigate the potential of \[TIMP-2\].\[IGFBP-7\] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-16
• Status Verified: 2016-10
• Primary Completion: 2017-07-31
• Study Completion: 2017-08-31
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ≥ 18 years
• High risk patients: General Surgery AKI Risk Index Class III, IV or V
• Major abdominal surgery

Exclusion Criteria

• Ongoing acute kidney injury Stage 2/3
• History of kidney transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
serum creatinine measurement	Nephro Check Test	This is the "Golden standard" to diagnose AKI
Nephro Check Test	serum creatinine measurement	We take urine samples and analyse the level of \[TIMP-2\]●\[IGFBP-7\] using the NephroCheck Test to diagnose AKI
Nephro Check Test	Nephro Check Test	We take urine samples and analyse the level of \[TIMP-2\]●\[IGFBP-7\] using the NephroCheck Test to diagnose AKI
serum creatinine measurement	serum creatinine measurement	This is the "Golden standard" to diagnose AKI

Primary Outcome Measures

Name	Time	Method
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines	72 Hours

Secondary Outcome Measures

Name	Time	Method
Number of participants who need renal replacement therapy	30 Days	the need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...)

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussels, Belgium