RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.

October 30, 2015 updated by: University Hospital, Bordeaux

Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.

Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.

Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop AKI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bordeaux
      • Pessac, Bordeaux, France, 33604
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.

Description

Inclusion Criteria:

  • Elective patients
  • Patients scheduled to receive an extracorporeal circulation
  • Patients aged 60 and older

  • Patients at risk of postoperative acute kidney injury presenting at least two of the following risk factors:

    • Age > 60 years.
    • Arteritis defined as severe lower limb arteriopathy or carotid stenosis > 50%
    • Diabetes
    • Valvular or combined surgery
    • Preoperative intra-aortic balloon pump.

Exclusion Criteria:

  • Unable to provide informed consent
  • Comatose patients
  • Patients with dementia
  • Patient who underwent a previous sternotomy
  • Chronic renal failure (sCr clearance < 30 ml.min-1)
  • Renal artery stenosis
  • Endocarditis
  • Emergent surgery
  • Nephrotoxic treatment
  • Non-sinus cardiac rhythm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal Resistive Index/Nephrocheck test
Patients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.
Procedure: Renal Resistive Index compared with NephroCheckTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Resistive Index compared with NephroCheckTM
Time Frame: Day 0 (inclusion) / after cardiac surgery
Compare the effectiveness of the IRR with the NephroCheckTM to predict AKI after cardiac surgery. AKI will be defined according to the RIFLE criteria.
Day 0 (inclusion) / after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Cédrick ZAOUTER, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 21, 2014

First Submitted That Met QC Criteria

December 21, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX RNI 02/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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