A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia

Phase 1

Not yet recruiting

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Oxygen; Drug: Room air

• Registration Number: NCT06327373
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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).

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Exclusion Criteria

• Daily supplemental oxygen use
• Inability to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Supplemental oxygen (0.5 liters per minute)	Oxygen	Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.
Supplemental oxygen (3 liters per minute)	Oxygen	Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.
Room air	Room air	Participants will receive no supplemental oxygen.

Primary Outcome Measures

Name	Time	Method
Change daily hypoxemia burden	Weeks 1, 2, and 3	Minutes with oxygen saturation \<90% over a 24-hour period assessed by pulse oximetry

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Davita Durham East; 🇺🇸 Durham, North Carolina, United States

Davita Research Triangle Park; 🇺🇸 Durham, North Carolina, United States

Davita Durham Downtown; 🇺🇸 Durham, North Carolina, United States

Davita Durham West; 🇺🇸 Durham, North Carolina, United States

Davita Durham Regional; 🇺🇸 Durham, North Carolina, United States

Davita Durham Southpoint; 🇺🇸 Durham, North Carolina, United States

Davita Bull City; 🇺🇸 Durham, North Carolina, United States

Davita Vance County; 🇺🇸 Henderson, North Carolina, United States

Davita Hope Valley; 🇺🇸 Durham, North Carolina, United States

Davita Kerr Lake; 🇺🇸 Henderson, North Carolina, United States

Davita Roxboro; 🇺🇸 Roxboro, North Carolina, United States