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Is Hypoxemia Driving Outcome in Acute Hypoxemic Respiratory Failure? (HOMELAND Study)
Sponsor: Jesus Villar
Summary
Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. The investigators will assess the value of mediation analysis (a statistical method to understand the mechanism or process through which an independent variable influences a dependent variable (prediction of early ICU death) via a mediator variable. This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF me, We had a database with 2,000,000 anonymized and dissociated demographics and clinical data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) registered with ClinicalTrails.gov (NCT013145974) from 22 Spanish hospitals and funded by the ISCIII. The study was approved by the Ethics Committees for Clinical research of participating hospitals and informed consent was waived based on Spanish legislation for biomedical research (Royal Decrees 1090/2015 and 957/2020). The investigators will use mediation analysis (Baron \& Kenny techniques) to clarify the association of extrapulmonary organ dysfunction and hypoxemia in the early prediction of ICU mortality. We will analyze 1,241 patients mechanically ventilated with AHRF at the time of diagnosis, 1,193 with data at 24 hours, and 996 patients with data at 48 hours from a epidemiological study in Spain.
Official title: Is the Degree of Hypoxemia Driving Outcome or is it a Marker of Overall Organ Dysfunction in Acute Hypoxemic Respiratory Failure?
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
1241
Start Date
2026-07-13
Completion Date
2027-07-29
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
mediation analysis
This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF mechanically ventilated.
Locations (18)
Department of Anesthesia, Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain
Complejo Hospitalario Universitario de Albacete (ICU)
Albacete, Spain
Hospital Clinic de Barcelona (AVI)
Barcelona, Spain
Hospital Clínic de Barcelona (Anesthesia)
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Complejo Asistencial Universitario de León (ICU)
León, Spain
Complejo Hospitalario Universitario de León
León, Spain
Department of Anesthesia, Hospital Universitario La Paz
Madrid, Spain
Department of Anesthesia, Hospital Universitario Virgen de Arrixaca
Murcia, Spain
Department of Anesthesia, Hospital Clinico Universitario
Valencia, Spain
Hospital Cinico de Valencia
Valencia, Spain
Hospital Clinico Universitario de Valencia (Anesthesia)
Valencia, Spain
Hospital Clinico de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Department of Anesthesia, Hospital Clínico Universitario
Valladolid, Spain
Anesthesia, Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Cardiff University
Cardiff, United Kingdom