NGAL Predictive Value of Acute Kidney Failure After Cardiac Surgery in Patients With Preoperative Chronic Kidney Failure (NGAL-CKF)

March 1, 2013 updated by: Prof. Sidney Chocron, Hopital Jean Minjoz

Plasmatic Level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a Predictive Marker of Acute Kidney Failure in Patients With Preoperative Chronic Kidney Failure Undergoing Cardiac Surgery.

Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.

Study Overview

Detailed Description

(N/A)

Study Type

Observational

Enrollment (Anticipated)

100

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

    • Franche-Comté
      • Besançon, Franche-Comté, France, 25000
        • Recruiting
        • Centre hospitalier Universitaire (CHU) Jean Minjoz
        • Contact:
        • Principal Investigator:
          • Chocron Sidney, MD, PhD
        • Sub-Investigator:
          • Andrea Perrotti, MD
        • Sub-Investigator:
          • Siamak Davani, MD, PhD
        • Sub-Investigator:
          • Camille Durst, MD

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

Non-Probability Sample

Study Population

Patients with a chronic kidney failure, undergoing cardiac surgery.

Description

Inclusion Criteria:

  • Renal clearance less than 60 mL/min
  • Able to give written consent
  • Elective valve surgery
  • Elective CABG surgery

Exclusion Criteria:

  • Less than 18 years old
  • Iodine injection within 3 days before surgery
  • Iodine injection within 24 first postoperative hours
  • preoperative infection
  • evolutive cancer disease
  • Refusal
  • Pregnancy
  • Unable to give written consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neutrophil Gelatinase Associated Lipocalin (NGAL) level
Time Frame: From surgery to discharge from hospital
From surgery to discharge from hospital

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Chocron Sidney, MD, PhD, Centre Hospitalier Universitaire (CHU) Jean Minjoz, Besançon, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

August 1, 2010

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

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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