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Could a breath of oxygen during dialysis ease a hidden heart risk?

NCT ID NCT06327373

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers at Duke University are testing whether giving supplemental oxygen during hemodialysis can improve pulmonary hypertension in adults whose oxygen levels drop during treatment. Participants receive either oxygen through a concentrator or room air during their regular dialysis sessions. The study measures daily low-oxygen episodes, walking distance, and thinking ability to see if this approach is feasible and worth further study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Supplemental oxygen delivered by an oxygen concentrator during hemodialysis sessions
What this could lead to
If it works, this could point toward a simple way to reduce pulmonary hypertension and improve daily oxygen levels in people on dialysis.
What could go wrong
This is an early feasibility study with a small number of participants, so it may not show clear benefits. The oxygen concentrator may be uncomfortable or impractical for some people during dialysis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary hypertension

Contacts and locations

Locations

  • Davita Bull City

    Durham, North Carolina, 27707, United States

  • Davita Durham Downtown

    Durham, North Carolina, 27703, United States

  • Davita Durham East

    Durham, North Carolina, 27701, United States

  • Davita Durham Regional

    Durham, North Carolina, 27704, United States

  • Davita Durham Southpoint

    Durham, North Carolina, 27713, United States

  • Davita Durham West

    Durham, North Carolina, 27705, United States

  • Davita Hope Valley

    Durham, North Carolina, 27713, United States

  • Davita Kerr Lake

    Henderson, North Carolina, 27537, United States

  • Davita Research Triangle Park

    Durham, North Carolina, 27703, United States

  • Davita Roxboro

    Roxboro, North Carolina, 27573, United States

  • Davita Vance County

    Henderson, North Carolina, 27536, United States

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