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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06327373
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniel Edmonston, MD, MHS
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension
Arms & Interventions

Arms

Placebo Comparator: Room air

Participants will receive no supplemental oxygen.

Experimental: 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.

Experimental: Supplemental oxygen (3 liters per minute)

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

Interventions

Drug: - Oxygen

Supplemental oxygen by oxygen concentrator

Drug: - Room air

Room air without oxygen concentrator

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Davita Durham East, Durham, North Carolina

Status

Address

Davita Durham East

Durham, North Carolina, 27701

Davita Durham Downtown, Durham, North Carolina

Status

Address

Davita Durham Downtown

Durham, North Carolina, 27703

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Research Triangle Park, Durham, North Carolina

Status

Address

Davita Research Triangle Park

Durham, North Carolina, 27703

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Durham Regional, Durham, North Carolina

Status

Address

Davita Durham Regional

Durham, North Carolina, 27704

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Durham West, Durham, North Carolina

Status

Address

Davita Durham West

Durham, North Carolina, 27705

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Bull City, Durham, North Carolina

Status

Address

Davita Bull City

Durham, North Carolina, 27707

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Durham Southpoint, Durham, North Carolina

Status

Address

Davita Durham Southpoint

Durham, North Carolina, 27713

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Hope Valley, Durham, North Carolina

Status

Address

Davita Hope Valley

Durham, North Carolina, 27713

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Vance County, Henderson, North Carolina

Status

Address

Davita Vance County

Henderson, North Carolina, 27536

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Kerr Lake, Henderson, North Carolina

Status

Address

Davita Kerr Lake

Henderson, North Carolina, 27537

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

Davita Roxboro, Roxboro, North Carolina

Status

Address

Davita Roxboro

Roxboro, North Carolina, 27573

Site Contact

Rachel Cooper

rachel.cooper@davita.com

720-261-8901

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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