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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2027-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Room air

Participants will receive no supplemental oxygen.

Group Type PLACEBO_COMPARATOR

Room air

Intervention Type DRUG

Room air without oxygen concentrator

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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

Supplemental oxygen by oxygen concentrator

Supplemental oxygen (3 liters per minute)

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

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

Supplemental oxygen by oxygen concentrator

Interventions

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Oxygen

Supplemental oxygen by oxygen concentrator

Intervention Type DRUG

Room air

Room air without oxygen concentrator

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Edmonston, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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