Clinical Research Directory
Browse clinical research sites, groups, and studies.
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Sponsor: Copenhagen University Hospital, Hvidovre
Summary
REDOX-AHF compared two oxygen saturation targets in adults admitted with acute heart failure and clinical or radiological signs of congestion. Participants were randomly assigned to a restrictive target of 89-91% or a liberal target of 95-97% for 24 hours. An automated oxygen delivery device adjusted oxygen flow while concealing the assigned target from participants and study staff. The main assessment was lung fluid content after 24 hours, measured noninvasively by remote dielectric sensing (ReDS). The trial was conducted at two Danish hospitals. A total of 135 participants were randomized; 134 remained in the modified intention-to-treat population after one participant withdrew consent. The target of 122 participants with complete primary-outcome measurements was reached. Follow-up continued to day 30.
Official title: Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2024-02-01
Completion Date
2026-03-03
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Oxygen
Patients will have nasal cannula or oxygen mask placed as the usual standard of care. Patients will be screened and randomized in the emergency department to either liberal or restrictive oxygenation after providing informed written consent and oxygen is titrated to the prespecified target range using an automated feedback device (O2MATIC). Consented patients will be randomly allocated to study groups via the web-based system within REDCap. The allocation will be concealed. Time at randomization will be considered as study time zero (T0). All patients will receive usual standard of care except for their O2 management. The intervention will last for 24 h. After 24 h, patients will be switched over to usual care for oxygen therapy. If the treating physician thinks, that the patient need another oxygenation target and it is thought to be harmful to continue with the allocated target, the intervention-phase can be stopped prematurely.
Locations (2)
Bispebjerg Hospital
Copenhagen, Denmark
Amager-Hvidovre Hospital
Hvidovre, Denmark