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

NCT ID: NCT02499185

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nephro Check Test

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

Group Type EXPERIMENTAL

Nephro Check Test

Intervention Type DEVICE

Urine sample

serum creatinine measurement

Intervention Type OTHER

Blood sample

serum creatinine measurement

This is the "Golden standard" to diagnose AKI

Group Type ACTIVE_COMPARATOR

Nephro Check Test

Intervention Type DEVICE

Urine sample

serum creatinine measurement

Intervention Type OTHER

Blood sample

Interventions

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Nephro Check Test

Urine sample

Intervention Type DEVICE

serum creatinine measurement

Blood sample

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lien Torisaen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Jan Poelaert, Prof.Dr.

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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NOVELBIO

Identifier Type: -

Identifier Source: org_study_id

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