- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01227122
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
Status
Unknown
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:
- CHOCRON Sidney, MD, PhD
- Phone Number: +33381668662
- Email: 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
-
-
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-A00111-38
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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