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

This study is currently recruiting participants.
Verified March 2013 by Hopital Jean Minjoz
Sponsor:
Information provided by (Responsible Party):
Prof. Sidney Chocron, Hopital Jean Minjoz
ClinicalTrials.gov Identifier:
NCT01227122
First received: October 22, 2010
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Preoperative KIDNEY FAILURE, CHRONIC
Postoperative KIDNEY FAILURE, ACUTE
Cardiac Surgical Procedures

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Jean Minjoz:

Primary Outcome Measures:
  • Neutrophil Gelatinase Associated Lipocalin (NGAL) level [ Time Frame: From surgery to discharge from hospital ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

(N/A)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Site of the department of Thoracic and Cardio-vascular surgery in Besançon, France  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Sidney Chocron, MD, PhD, Hopital Jean Minjoz
ClinicalTrials.gov Identifier: NCT01227122     History of Changes
Other Study ID Numbers: 2010-A00111-38
Study First Received: October 22, 2010
Last Updated: March 1, 2013
Health Authority: France: Agence Française Sécurité Sanitaire des Produits de Santé (AFSSAPS)

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

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

ClinicalTrials.gov processed this record on May 22, 2013