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NCT Number: NCT07708506

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesia, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain

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About this study

Background: Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide.

Objectives: The investigators will asess 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 mechanically ventilated.

Methods: The investigators 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) 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. The investigators 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • intubation and mechanical ventilation PaO2/FiO2 ratio < or = 300 mmHg under MV with PEEP > or = 5 cmH2O, and FiO2 > 0r = 0.3

Exclusion criteria

  • Brain death patients

Treatment and study plan

mediation analysis

Diagnostic Test

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.

Primary outcomes

  1. Death in the intensive care unit (ICU)

    Time frame: up to 100 weeks

    prediction of ICU death

Sponsors and collaborators

Lead sponsor

Jesus Villar

Other

Collaborators

  • Hospital Universitario de Gran Canaria Doctor Negrín

Registry information

Official study title

Is the Degree of Hypoxemia Driving Outcome or is it a Marker of Overall Organ Dysfunction in Acute Hypoxemic Respiratory Failure?

Acronym: HOMELAND

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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