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 — DRUG
    Supplemental oxygen by oxygen concentrator
  • Room air — DRUG
    Room 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 air
    Participants 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

Locations (11)

FacilityCityStateZIPSite coordinators
Davita Bull CityDurhamNorth Carolina27707
Rachel Cooper
720-261-8901
Davita Durham DowntownDurhamNorth Carolina27703
Rachel Cooper
720-261-8901
Davita Durham EastDurhamNorth Carolina27701-
Davita Durham RegionalDurhamNorth Carolina27704
Rachel Cooper
720-261-8901
Davita Durham SouthpointDurhamNorth Carolina27713
Rachel Cooper
720-261-8901
Davita Durham WestDurhamNorth Carolina27705
Rachel Cooper
720-261-8901
Davita Hope ValleyDurhamNorth Carolina27713
Rachel Cooper
720-261-8901
Davita Research Triangle ParkDurhamNorth Carolina27703
Rachel Cooper
720-261-8901
Davita Kerr LakeHendersonNorth Carolina27537
Rachel Cooper
720-261-8901
Davita Vance CountyHendersonNorth Carolina27536
Rachel Cooper
720-261-8901
Davita RoxboroRoxboroNorth Carolina27573
Rachel Cooper
720-261-8901

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