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

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ClinicalTrials.gov Identifier: NCT01227122
Recruitment Status : Unknown
Verified March 2013 by Prof. Sidney Chocron, Hopital Jean Minjoz.
Recruitment status was:  Recruiting
First Posted : October 25, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Sidney Chocron, Hopital Jean Minjoz

Brief Summary:
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.

Condition or disease
Preoperative KIDNEY FAILURE, CHRONIC Postoperative KIDNEY FAILURE, ACUTE Cardiac Surgical Procedures

Detailed Description:
(N/A)

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.
Study Start Date : August 2010
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Neutrophil Gelatinase Associated Lipocalin (NGAL) level [ Time Frame: From surgery to discharge from hospital ]

Biospecimen Retention:   Samples Without DNA
Blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a chronic kidney failure, undergoing cardiac surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227122


Locations
France
Centre hospitalier Universitaire (CHU) Jean Minjoz Recruiting
Besançon, Franche-Comté, France, 25000
Contact: CHOCRON Sidney, MD, PhD    +33381668662    sidney.chocron@univ-fcomte.fr   
Principal Investigator: Chocron Sidney, MD, PhD         
Sub-Investigator: Andrea Perrotti, MD         
Sub-Investigator: Siamak Davani, MD, PhD         
Sub-Investigator: Camille Durst, MD         
Sponsors and Collaborators
Hopital Jean Minjoz
Investigators
Principal Investigator: Chocron Sidney, MD, PhD Centre Hospitalier Universitaire (CHU) Jean Minjoz, Besançon, France

Additional Information:
Responsible Party: Prof. Sidney Chocron, MD, PhD, Hopital Jean Minjoz
ClinicalTrials.gov Identifier: NCT01227122     History of Changes
Other Study ID Numbers: 2010-A00111-38
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by Prof. Sidney Chocron, Hopital Jean Minjoz:
NGAL plasmatic level
Preoperative KIDNEY FAILURE, CHRONIC
Postoperative KIDNEY FAILURE, ACUTE
Cardiac Surgery Procedures

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic