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ACTIVE NOT RECRUITING
NCT07708506

Is Hypoxemia Driving Outcome in Acute Hypoxemic Respiratory Failure? (HOMELAND Study)

Sponsor: Jesus Villar

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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