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The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Room air | Placebo Comparator | Participants will receive no supplemental oxygen. |
|
| Supplemental oxygen (0.5 liters per minute) | Experimental | Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute. |
|
| Supplemental oxygen (3 liters per minute) | Experimental | Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Supplemental oxygen by oxygen concentrator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change daily hypoxemia burden | Minutes with oxygen saturation <90% over a 24-hour period assessed by pulse oximetry | Weeks 1, 2, and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in six minute walk distance | Scores are measured as meters walked during a six-minute assessment | Weeks 1 and 3 |
| Change in Montreal Cognitive Assessment (MoCA) | Scores are measured on a 30-point scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastacia Bohannon | Contact | 919-668-3376 | anastacia.bohannon@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Edmonston, MD, MHS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davita Durham East | Durham | North Carolina | 27701 | United States | ||
| Davita Durham Downtown |
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| Room air | Drug | Room air without oxygen concentrator |
|
| Weeks 1 and 3 |
| Durham |
| North Carolina |
| 27703 |
| United States |
|
| Davita Research Triangle Park | Durham | North Carolina | 27703 | United States |
|
| Davita Durham Regional | Durham | North Carolina | 27704 | United States |
|
| Davita Durham West | Durham | North Carolina | 27705 | United States |
|
| Davita Bull City | Durham | North Carolina | 27707 | United States |
|
| Davita Durham Southpoint | Durham | North Carolina | 27713 | United States |
|
| Davita Hope Valley | Durham | North Carolina | 27713 | United States |
|
| Davita Vance County | Henderson | North Carolina | 27536 | United States |
|
| Davita Kerr Lake | Henderson | North Carolina | 27537 | United States |
|
| Davita Roxboro | Roxboro | North Carolina | 27573 | United States |
|
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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