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NCT06327373 Clinical Trial

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

Pulmonary Hypertension Clinical Trial

— SOPHIE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06327373
Other study ID # Pro00114903
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2025

Study information
Verified date March 2024
Source Duke University
Contact Anastacia Bohannon
Phone 919-668-3376
Email anastacia.bohannon@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Davita Bull City Durham North Carolina
United States Davita Durham Downtown Durham North Carolina
United States Davita Durham East Durham North Carolina
United States Davita Durham Regional Durham North Carolina
United States Davita Durham Southpoint Durham North Carolina
United States Davita Durham West Durham North Carolina
United States Davita Hope Valley Durham North Carolina
United States Davita Research Triangle Park Durham North Carolina
United States Davita Kerr Lake Henderson North Carolina
United States Davita Vance County Henderson North Carolina
United States Davita Roxboro Roxboro North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change daily hypoxemia burden Minutes with oxygen saturation <90% over a 24-hour period assessed by pulse oximetry Weeks 1, 2, and 3
Secondary Change in six minute walk distance Scores are measured as meters walked during a six-minute assessment Weeks 1 and 3
Secondary Change in Montreal Cognitive Assessment (MoCA) Scores are measured on a 30-point scale Weeks 1 and 3
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