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

NCT02499185 | Terminated Phase 4

• 1 other identifier: NOVELBIO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Biomarker; Intra Abdominal Surgery; AKI

Outcome Measures

Primary Outcomes (1)

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

  72 Hours

Secondary Outcomes (1)

• Number of participants who need renal replacement therapy

  30 Days

Other Outcomes (2)

• 30-day mortality

  30 days

• persistence of renal dysfunction at 30 days

  30 days

Study Arms (2)

Nephro Check Test

EXPERIMENTAL

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

Device: Nephro Check Test; Other: serum creatinine measurement

serum creatinine measurement

ACTIVE COMPARATOR

This is the "Golden standard" to diagnose AKI

Device: Nephro Check Test; Other: serum creatinine measurement

Interventions

Nephro Check Test DEVICE

Urine sample

Nephro Check Test; serum creatinine measurement

serum creatinine measurement OTHER

Blood sample

Nephro Check Test; serum creatinine measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Acute Kidney Injury; Hypertension; Obesity; Diabetes Mellitus; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Lien Torisaen, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Jan Poelaert, Prof.Dr.

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Data Nurse

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 16, 2015
• Study Start: April 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: October 15, 2018

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)