Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Preven… (NCT02651428) | Clinical Trial Compass
CompletedPhase 3
Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
United States806 participantsStarted 2015-12
Plain-language summary
The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has ESRD and undergoes chronic HD at least two times per week
✓. Subject has a HD catheter that has demonstrated the ability to achieve a minimum blood flow of at least 250 mL/min for at least two consecutive dialysis sessions blood flow to enable successful HD
✓. The HD catheter is implanted with the tip in a jugular or subclavian vein
✓. The subject is not expected to expire within 180 days
✓. The subject is likely to require the use of a CVC for at least 90 days
✓. The subject (or the legal guardian) understands the nature of the study and provides written informed consent prior to the study enrollment
✓. The subject is willing to comply with specified follow-up evaluations and prescribed dialysis therapy and
✓. If female and of childbearing potential, the subject must have a negative pregnancy test at the screening visit (i.e., subject is not pregnant); not be lactating; and use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or hormonal contraceptive (oral, implant, ring, patch) for the duration of the study. (NOTE: The subject must have used the chosen method of birth control for at least 1 month/cycle prior to enrollment into the study).
Exclusion criteria
✕. Subjects who received antibiotics within the last 14 days
✕. Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection
What they're measuring
1
Presence of a CAC-Adjudicated Catheter-Related Bloodstream Infection (CRBSI) in Subjects Receiving Hemodialysis for the Treatment of End Stage Renal Disease (ESRD): Final Analysis
Timeframe: The event time was the number of days from randomization until the occurrence of a CAC-Adjudicated CRBSI or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).