Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
Condition: Kidney Failure, Chronic; Catheter-Related Infections
MeSH terms: Infections; Communicable Diseases; Sepsis; Catheter-Related Infections; Renal Insufficiency; Kidney Failure, Chronic
Intervention: Neutrolin; Heparin
Intervention description: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session; Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
Intervention MeSH terms: Taurolidine; Heparin; Calcium heparin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 806.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Failure, Chronic; Catheter-Related Infections; Central Venous Catheter

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has ESRD and undergoes chronic HD at least two times per week

          2. 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

          3. The HD catheter is implanted with the tip in a jugular or subclavian vein

          4. The subject is not expected to expire within 180 days

          5. The subject is likely to require the use of a CVC for at least 90 days

          6. The subject (or the legal guardian) understands the nature of the study and provides
             written informed consent prior to the study enrollment

          7. The subject is willing to comply with specified follow-up evaluations and prescribed
             dialysis therapy and

          8. 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:

          1. Subjects who received antibiotics within the last 14 days

          2. Visible evidence of compromised skin integrity is present at the catheter exit site or
             evidence of a catheter exit site infection

          3. Subject has received any thrombolytic treatment (i.e., tPA) in their current catheter
             within 30 days of randomization

          4. Fill volume of HD catheter is unknown or cannot be determined

          5. Subjects using any type of antimicrobial-coated or heparin-coated catheter

          6. Documented chronic bleeding diathesis, active or recurrent bleeding within 1 month
             prior to randomization

          7. Documented history of an atrial thrombus or known hypercoagulable state

          8. Subjects with open, non-healing skin ulcers

          9. Current requirement for systemic immunosuppression that would increase risk of
             infection

         10. Active malignancy requiring or anticipated to require chemotherapy likely to cause
             leukopenia and/or immunosuppression

         11. Known allergy or absolute contraindication to citrate, taurolidine or heparin or a
             history of heparin-induced thrombocytopenia

         12. Unstable malignancy

         13. Cirrhosis with encephalopathy

         14. Subject is currently taking another medication with known systemic drug interaction
             with citrate, taurolidine, or heparin

         15. Subject is currently enrolled in another investigational device and/or drug trial or
             has participated in another investigational device and/or drug trial within 30 days
             prior to enrollment

         16. Subject is anticipated to receive a renal transplant within 90 days (subjects can be
             on the transplant list, but a subject with a known or anticipated transplant date
             within the next 90 days should be excluded)

         17. Any other medical condition which renders the subject unable to or unlikely to
             complete the study, or which would interfere with optimal participation in the study
             or produce significant risk to the subject.

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