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

Phase 4TerminatedNCT02499185

Universitair Ziekenhuis Brussel100 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

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

Interventions

Nephro Check TestDEVICE

Urine sample

serum creatinine measurementOTHER

Blood sample

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Outcomes

Primary Outcomes

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

Time frame: 72 Hours

Secondary Outcomes

Number of participants who need renal replacement therapy

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

Time frame: 30 Days

Data from ClinicalTrials.gov

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