search
Back to results

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

Primary Purpose

Acute Kidney Injury, Arterial Hypertension, Obesity

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Nephro Check Test
serum creatinine measurement
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring Biomarker, Intra Abdominal Surgery, AKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nephro Check Test

serum creatinine measurement

Arm Description

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

This is the "Golden standard" to diagnose AKI

Outcomes

Primary Outcome Measures

Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2015
Last Updated
October 10, 2018
Sponsor
Universitair Ziekenhuis Brussel
search

1. Study Identification

Unique Protocol Identification Number
NCT02499185
Brief Title
Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients
Official Title
A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
No patients with renal failure
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Arterial Hypertension, Obesity, Cardio Vascular Disease, Diabetes Mellitus, Chronic Liver Disease, Hypercholesterolemia
Keywords
Biomarker, Intra Abdominal Surgery, AKI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nephro Check Test
Arm Type
Experimental
Arm Description
We take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI
Arm Title
serum creatinine measurement
Arm Type
Active Comparator
Arm Description
This is the "Golden standard" to diagnose AKI
Intervention Type
Device
Intervention Name(s)
Nephro Check Test
Intervention Description
Urine sample
Intervention Type
Other
Intervention Name(s)
serum creatinine measurement
Intervention Description
Blood sample
Primary Outcome Measure Information:
Title
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
Time Frame
72 Hours
Secondary Outcome Measure Information:
Title
Number of participants who need renal replacement therapy
Description
the need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...)
Time Frame
30 Days
Other Pre-specified Outcome Measures:
Title
30-day mortality
Time Frame
30 days
Title
persistence of renal dysfunction at 30 days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lien Torisaen, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, Prof.Dr.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs