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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02499185
• Other study ID #: NOVELBIO
• Status: Terminated
• Phase: Phase 4
• Start date: April 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: August 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Nephro Check Test
Urine sample

Other:
• serum creatinine measurement
Blood sample

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day mortality		30 days
Other	persistence of renal dysfunction at 30 days		30 days
Primary	Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines		72 Hours
Secondary	Number of participants who need renal replacement therapy	the need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...)	30 Days