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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01227122
Other study ID # 2010-A00111-38
Secondary ID
Status Recruiting
Phase N/A
First received October 22, 2010
Last updated March 1, 2013
Start date August 2010
Est. completion date September 2013

Study information

Verified date March 2013
Source Hopital Jean Minjoz
Contact n/a
Is FDA regulated No
Health authority France: Agence Française Sécurité Sanitaire des Produits de Santé (AFSSAPS)
Study type Observational

Clinical Trial 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.


Description:

(N/A)


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre hospitalier Universitaire (CHU) Jean Minjoz Besançon Franche-Comté

Sponsors (1)

Lead Sponsor Collaborator
Hopital Jean Minjoz

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neutrophil Gelatinase Associated Lipocalin (NGAL) level From surgery to discharge from hospital No
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