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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT00863603
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80+/- referred and considered a candidate for a synthetic hemodialysis access graft.
2. Baseline room air arterial blood concentration \>70 and arterial carbon dioxide concentration 45 mmHg. Pulmonary function tests \> 75% predicted values
3. Currently undergoing dialysis
4. No previous synthetic hemodialysis grafts placed in the same arm (fistula in ipsilateral arm permitted)
5. Ability to use 5L/minute supplemental oxygen by nasal cannula
6. Nonsmoker, able to avoid other situations which would constitute a risk for use of oxygen
7. Medical condition with \> 1 year life expectancy
8. Currently on no medications which would interfere with wound healing (i.e. steroids, chemotherapeutic agents)
9. Not pregnant nor planning to become pregnant during study period
Exclusion Criteria:
1. Failure to meet inclusion criteria
2. Failure to comply with study protocol for 3 consecutive days during the 6 wk oxygen/non-oxygen supplement period immediately following graft placement
3. Medical condition developing during study period causing a significantly worsening pulmonary function requiring supplemental oxygen for \> 3 days
4. Need to take medication during study period which would interfere with wound healing any time during the 6 week period immediately following graft placement or need to take chronic medications (\> 6 weeks) during the remainder of the study period.
5. Patient desire to withdraw
6. Failure of evidence of adequate increase in arterial blood oxygen concentration (pa02 \> 115 for oxygen supplemented and pa02 \> 55 mmHg for control obtained from arterial access port during dialysis run
7. Failure to use supplemental oxygen (if in supplemental oxygen group) at least 18 hours per day (as recorded in journal) -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00863603
Study Brief:
Protocol Section:
NCT00863603