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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03519360
Eligibility Criteria:
Inclusion Criteria:
* Maintenance hemodialysis therapy for end-stage renal disease
* Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
* \>30 days since dialysis initiation
* Ability to provide informed consent
* Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment
Exclusion Criteria:
* Expected survival \<6 months-to allow trial completion
* Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
* Prisoners or cognitive disability preventing informed consent
* Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential \>55 years old, women with a history of surgical sterilization, or for women \<55 years of age who have not had a menses within the past 12 months
* Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
* Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
* Existing pacemaker, implantable monitor or defibrillator which precludes device placement
* Chronic, persistent AF (defined as the presence of persistent AF on all available EKGs at time of recent screening)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03519360
Study Brief:
Protocol Section:
NCT03519360