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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02002169
Eligibility Criteria:
Inclusion Criteria
* Informed written consent obtained (English speaking)
* Age \>18 years
* Requires a CVC as the vascular access: a) end stage kidney disease without a functioning surgically created access; b) end stage kidney disease whose peritoneal dialysis problems require transfer to HD for an anticipated prolonged period
* Passed 2/3 tests of CVC exit site healing (see below)
* Must be willing and able to take a shower as the standard form of body cleansing if randomized to STP
* Trisodium citrate (4%) as standard CVC locking solution
* CVC has been in situ for \> 6 weeks
Exclusion criteria
* Acute kidney failure, likely to be reversible with recovery of renal function
* Non-Tunneled CVC
* Antibiotic use by any route in the week prior to enrolling in the study, including intranasal mupirocin
* On immunosuppressant therapy
* Use of the CVC for purposes other than access for hemodialysis
* Involvement in another interventional study related to their vascular access
* CVC or patient life expectancy \<6 months (e.g. active malignancy; serious comorbidity such as hepatic failure)
* Routine use of tissue plasminogen activator or antibiotic as a locking solution
* CVC insertion in location other than the neck/chest region (IJ or subclavian acceptable)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02002169
Study Brief:
Protocol Section:
NCT02002169