Pulmonary Hypertension
Conditions
Brief summary
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.
Interventions
DRUGOxygen
Supplemental oxygen by oxygen concentrator
DRUGRoom air
Room air without oxygen concentrator
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years * Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis * Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity \[TRV\] \>2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation \<90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to \<88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).
Exclusion criteria
* Daily supplemental oxygen use * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change daily hypoxemia burden | Weeks 1, 2, and 3 | Minutes with oxygen saturation \<90% over a 24-hour period assessed by pulse oximetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in six minute walk distance | Weeks 1 and 3 | Scores are measured as meters walked during a six-minute assessment |
| Change in Montreal Cognitive Assessment (MoCA) | Weeks 1 and 3 | Scores are measured on a 30-point scale |
Countries
United States
Contacts
Primary ContactAnastacia Bohannon
Outcome results
None listed