Bacteremia Clinical Trial
— ALLOCKOfficial title:
Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
NCT number | NCT00571259 |
Other study ID # | SR001AL |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2003 |
Est. completion date | January 2010 |
Verified date | September 2021 |
Source | Satellite Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
Status | Completed |
Enrollment | 303 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Satellite Healthcare, Inc | Mountain View | California |
Lead Sponsor | Collaborator |
---|---|
Satellite Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Device-related Bacteremia | Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection | 5 years | |
Secondary | Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow | The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting. | 5 years |
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