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

Duke University

Status and phase: Begins enrollment in 4 months; Phase 2; Phase 1

Conditions: Pulmonary Hypertension

Treatments: Drug: Oxygen; Drug: Room air

Study type: Interventional

Funder types: Other

Identifiers

NCT06327373

Pro00114903

Details and patient eligibility

About

The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 3 patient groups, including a placebo group

Room air

Placebo Comparator group

Description:

Participants will receive no supplemental oxygen.

Treatment:

Drug: Room air

Supplemental oxygen (0.5 liters per minute)

Experimental group

Description:

Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.

Treatment:

Drug: Oxygen

Supplemental oxygen (3 liters per minute)

Experimental group

Description:

Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.

Treatment:

Drug: Oxygen