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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07708506
Acronym
HOMELAND
Enrollment
1241
Registered
2026-07-16
Start date
2026-07-13
Completion date
2027-07-29
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

mechanical ventilation, mediation analysis, outcome

Brief 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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTmediation 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.

Sponsors

Jesus Villar
Lead SponsorOTHER
Hospital Universitario de Gran Canaria Doctor Negrín
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Death in the intensive care unit (ICU)up to 100 weeksprediction of ICU death

Countries

Spain, United Kingdom

Contacts

STUDY_CHAIRJesus Villar

Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026