Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT00571259
Eligibility Criteria:
Inclusion Criteria:
* Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
* Must be at least 18 years old
* Compliant with a dialysis treatment schedule
* Plans to continue hemodialysis treatment and follow-up at the investigational site
* Must be able to care for the exit site independently or have someone who is able to care for the site for them
* Must be able to sign the informed consent document
Exclusion Criteria:
* The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
* Active exit site or tunnel infection
* Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
* Known to have antibodies to heparin
* Allergy to pork heparin
* Allergy to gentamicin
* Subject is pregnant
* Known intravenous drug abuse
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00571259
Study Brief:
Protocol Section:
NCT00571259