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

NCT07708506 | Active Not Recruiting DMC

• 1 other identifier: PIFIISC26
• Study Type: observational
• Target: 1,241
• Locations: 2 countries
• Sites: 18

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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

mechanical ventilation; mediation analysis; outcome

Outcome Measures

Primary Outcomes (1)

• Death in the intensive care unit (ICU)

  prediction of ICU death

  up to 100 weeks

Study Arms (3)

Time on admission

The investigators will use 1241 at the time of meeting AHRF (t0)

Diagnostic Test: mediation analysis

Time 24

The investigaotros will use 1193 patients with AHRF, with completed data after 24 hours of mechanical ventilation

Diagnostic Test: mediation analysis

Time 48

The investigaotros will use 996 patients with AHRF with completed data after 48 hours of mechanical ventilation

Diagnostic Test: mediation analysis

Interventions

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.

Time 24; Time 48; Time on admission

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients, intubated and mechanically ventilated, with acute hupoxemic respiratory failure (AHRF)

You may qualify if:

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

You may not qualify if:

• Brain death patients

Sponsors & Collaborators

• Jesus Villar: lead
• Hospital Universitario de Gran Canaria Doctor Negrín: collaborator

Study Sites (18)

Department of Anesthesia, Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Complejo Hospitalario Universitario de Albacete (ICU)

Albacete, 02006, Spain

Location

Hospital Clinic de Barcelona (AVI)

Barcelona, 08036, Spain

Location

Hospital Clínic de Barcelona (Anesthesia)

Barcelona, 08036, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Complejo Asistencial Universitario de León (ICU)

León, 24001, Spain

Location

Complejo Hospitalario Universitario de León

León, Spain

Location

Department of Anesthesia, Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Department of Anesthesia, Hospital Universitario Virgen de Arrixaca

Murcia, 30120, Spain

Location

Department of Anesthesia, Hospital Clinico Universitario

Valencia, 46010, Spain

Location

Hospital Cinico de Valencia

Valencia, 46010, Spain

Location

Hospital Clinico Universitario de Valencia (Anesthesia)

Valencia, 46010, Spain

Location

Hospital Clinico de Valencia

Valencia, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Department of Anesthesia, Hospital Clínico Universitario

Valladolid, 47003, Spain

Location

Anesthesia, Hospital Universitario Río Hortega

Valladolid, 47012, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Cardiff University

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jesus Villar

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator and scientificc advisor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): July 29, 2027
• Study Completion (Estimated): July 29, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); ES (17)