A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT06327373
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Pulmonary Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Oxygen — DRUGSupplemental oxygen by oxygen concentrator
- Room air — DRUGRoom air without oxygen concentrator
Study Details
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Aug 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Room airParticipants will receive no supplemental oxygen.
- Experimental: Supplemental oxygen (0.5 liters per minute)Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.
- Experimental: Supplemental oxygen (3 liters per minute)Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.
Primary Outcome Measure
Change daily hypoxemia burden [ Time Frame: Weeks 1, 2, and 3 ]
Central Contacts
- Anastacia Bohannon919-668-3376
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Davita Bull City | Durham | North Carolina | 27707 | |
| Davita Durham Downtown | Durham | North Carolina | 27703 | |
| Davita Durham East | Durham | North Carolina | 27701 | - |
| Davita Durham Regional | Durham | North Carolina | 27704 | |
| Davita Durham Southpoint | Durham | North Carolina | 27713 | |
| Davita Durham West | Durham | North Carolina | 27705 | |
| Davita Hope Valley | Durham | North Carolina | 27713 | |
| Davita Research Triangle Park | Durham | North Carolina | 27703 | |
| Davita Kerr Lake | Henderson | North Carolina | 27537 | |
| Davita Vance County | Henderson | North Carolina | 27536 | |
| Davita Roxboro | Roxboro | North Carolina | 27573 |
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