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

Universitair Ziekenhuis Brussel

Status and phase: Terminated; Phase 4

Conditions: Chronic Liver Disease; Hypercholesterolemia; Acute Kidney Injury; Diabetes Mellitus; Arterial Hypertension; Obesity; Cardio Vascular Disease

Treatments: Device: Nephro Check Test; Other: serum creatinine measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02499185

NOVELBIO

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Nephro Check Test

Experimental group

Description:

We take urine samples and analyse the level of \[TIMP-2\]●\[IGFBP-7\] using the NephroCheck Test to diagnose AKI

Treatment:

Other: serum creatinine measurement

Device: Nephro Check Test

serum creatinine measurement

Active Comparator group

Description:

This is the "Golden standard" to diagnose AKI

Treatment:

Other: serum creatinine measurement

Device: Nephro Check Test