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Not yet recruiting NCT06327373

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

Phase I / Phase II Interventional Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxygen, Room air.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug Oxygen
    Supplemental oxygen by oxygen concentrator
  • Drug Room air
    Room air without oxygen concentrator

Primary outcome measures

  • Change daily hypoxemia burden [Time frame: Weeks 1, 2, and 3]
Secondary outcome measures (2)
  • Change in six minute walk distance [Time frame: Weeks 1 and 3]
  • Change in Montreal Cognitive Assessment (MoCA) [Time frame: Weeks 1 and 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • Davita Durham East — Durham
  • Davita Durham Downtown — Durham
  • Davita Research Triangle Park — Durham
  • Davita Durham Regional — Durham
  • Davita Durham West — Durham
  • Davita Bull City — Durham
  • Davita Durham Southpoint — Durham
  • Davita Hope Valley — Durham
  • … and 3 more centers

Identifiers

NCT: NCT06327373 · Pro00114903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗