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

October 10, 2018 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nephro Check Test
We take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI
Device: Nephro Check Test
Urine sample
Other: serum creatinine measurement
Blood sample
Active Comparator: serum creatinine measurement
This is the "Golden standard" to diagnose AKI
Device: Nephro Check Test
Urine sample
Other: serum creatinine measurement
Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
Time Frame: 72 Hours
72 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who need renal replacement therapy
Time Frame: 30 Days
the need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...)
30 Days

Other Outcome Measures

Outcome Measure
Time Frame
30-day mortality
Time Frame: 30 days
30 days
persistence of renal dysfunction at 30 days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Lien Torisaen, MD, Universitair Ziekenhuis Brussel
  • Study Chair: Jan Poelaert, Prof.Dr., Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOVELBIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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