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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02499185
Enrollment
100
Registered
2015-07-16
Start date
2015-04-01
Completion date
2017-08-31
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Biomarker, Intra Abdominal Surgery, AKI

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.

Interventions

DEVICENephro Check Test

Urine sample

OTHERserum creatinine measurement

Blood sample

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle KDIGO guidelines72 Hours

Secondary

MeasureTime frameDescription
Number of participants who need renal replacement therapy30 Daysthe need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...)

Other

MeasureTime frame
30-day mortality30 days
persistence of renal dysfunction at 30 days30 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026