Status:
COMPLETED
REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX)
Lead Sponsor:
Skane University Hospital
Collaborating Sponsors:
Lund University
Blekinge County Council Hospital
Conditions:
Chronic Respiratory Failure With Hypoxia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Multicenter, phase IV, non-superiority, registry-based, randomized controlled trial. Patients starting long-term oxygen therapy (LTOT) are randomized between LTOT prescribed 24 h/day or 15 h/day using...
Detailed Description
BACKGROUND: LTOT given 15 h/day or more improves the survival time in patients with chronic daytime hypoxemia due to chronic obstructive pulmonary disease (COPD) based on two randomized trials; the '...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Severe resting hypoxemia (PaO2 \< 7.4 kPa or oxygen saturation \< 88% breathing air), or PaO2 \< 8.0 kPa on air and either signs of heart failure or polycythemia (EVF \> 0.54).
Exclusion
- Smoking or contact with open fire
- Other inability to safely comply with LTOT
- Already on LTOT for more than 28 days
- Inability to comply with any of the study interventions as judged by the responsible oxygen staff
- Opt out from being registered in Swedevox
- Inability to give informed written consent to participate in the study as judged by the oxygen responsible staff
- Lack of Swedish identification number
- Previous participation in the study.
- Patient populations that will be evaluated:
- Primary analysis: In all randomized patients according to the intention-to-treat and per protocol principles.
- Secondary analyses: In patients with 1) PaO2 (air) \< 7.4 kPa; 2) PaO2 (air) 7.4 to 8.0 kPa; 3) COPD verified by spirometry (COPD as primary diagnosis and FEV1/FVC \< 0.7 after bronchodilation); 4) and in patients with a primary diagnosis other than COPD.
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT03441204
Start Date
May 16 2018
End Date
April 4 2023
Last Update
April 8 2024
Active Locations (2)
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1
Blekinge hospital
Karlskrona, Blekinge County, Sweden, SE-37185
2
Örebro University Hospital
Örebro, Sweden, SE-70185