Acute Hypoxemic Respiratory FailureHOMELANDNCT07708506
Is Hypoxemia Driving Outcome in Acute Hypoxemic Respiratory Failure? (HOMELAND Study)
An observational study of Acute Hypoxemic Respiratory Failure, run by Jesus Villar at 18 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- mediation analysis
- How many people
- 1,241 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 13 Jul 2026to 29 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients, intubated and mechanically ventilated, with acute hupoxemic respiratory failure (AHRF)
Who may be able to join
- intubation and mechanical ventilation PaO2/FiO2 ratio < or = 300 mmHg under MV with PEEP > or = 5 cmH2O, and FiO2 > 0r = 0.3
Who cannot join
- Brain death patients
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Spain17 sites
Complejo Hospitalario Universitario de Albacete (ICU)
Albacete, 02006
Department of Anesthesia, Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903
Hospital Clinic de Barcelona (AVI)
Barcelona, 08036
Hospital Clínic de Barcelona (Anesthesia)
Barcelona, 08036
Hospital Clinic
Barcelona
Complejo Asistencial Universitario de León (ICU)
León, 24001
Complejo Hospitalario Universitario de León
León
Department of Anesthesia, Hospital Universitario La Paz
Madrid, 28046
Department of Anesthesia, Hospital Universitario Virgen de Arrixaca
Murcia, 30120
Department of Anesthesia, Hospital Clinico Universitario
Valencia, 46010
Hospital Cinico de Valencia
Valencia, 46010
Hospital Clinico Universitario de Valencia (Anesthesia)
Valencia, 46010
Hospital Clinico de Valencia
Valencia
Hospital Clínico Universitario de Valencia
Valencia
Department of Anesthesia, Hospital Clínico Universitario
Valladolid, 47003
Anesthesia, Hospital Universitario Río Hortega
Valladolid, 47012
Hospital Clínico Universitario de Valladolid
Valladolid
About this study
Official title: Is the Degree of Hypoxemia Driving Outcome or is it a Marker of Overall Organ Dysfunction in Acute Hypoxemic Respiratory Failure?
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.
Read the 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.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- mediation analysis
- Keywords
- mechanical ventilation, mediation analysis, outcome
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediation analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Time on admission | The investigators will use 1241 at the time of meeting AHRF (t0) Receives: Diagnostic Test: mediation analysis | |
| Time 24 | The investigaotros will use 1193 patients with AHRF, with completed data after 24 hours of mechanical ventilation Receives: Diagnostic Test: mediation analysis | |
| Time 48 | The investigaotros will use 996 patients with AHRF with completed data after 48 hours of mechanical ventilation Receives: Diagnostic Test: mediation analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death in the intensive care unit (ICU)
prediction of ICU death
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start13 Jul 2026
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesus Villar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Gran Canaria Doctor Negrín
- Responsible party
- Sponsor-investigator, Jesus Villar, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Jesus Villar, Study chair, Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708506
- Sponsor's protocol ID
- PIFIISC26
- Acronym
- HOMELAND
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Degree of Hypoxemia Driving Outcome or is it a Marker of Overall Organ Dysfunction in Acute Hypoxemic Respiratory Failure?
- ClinicalTrials.gov ID
- NCT07708506
- Acronym / sponsor ID
- HOMELAND / PIFIISC26
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- mechanical ventilation, mediation analysis, outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,241 participants (estimated)
- Lead sponsor
- Jesus VillarUniversity, hospital or other
- Collaborators
- Hospital Universitario de Gran Canaria Doctor Negrín
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 29 Jul 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time on admission | – | Diagnostic Test: mediation analysisThe investigators will use 1241 at the time of meeting AHRF (t0) |
| Time 24 | – | Diagnostic Test: mediation analysisThe investigaotros will use 1193 patients with AHRF, with completed data after 24 hours of mechanical ventilation |
| Time 48 | – | Diagnostic Test: mediation analysisThe investigaotros will use 996 patients with AHRF with completed data after 48 hours of mechanical ventilation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients, intubated and mechanically ventilated, with acute hupoxemic respiratory failure (AHRF)
Key inclusion criteria (1 listed)
- intubation and mechanical ventilation PaO2/FiO2 ratio < or = 300 mmHg under MV with PEEP > or = 5 cmH2O, and FiO2 > 0r = 0.3
Key exclusion criteria (1 listed)
- Brain death patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mediation analysisThis 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. | Diagnostic test | Time 24, Time 48, Time on admission |
Primary outcome
Death in the intensive care unit (ICU)
Time frame: up to 100 weeks
prediction of ICU death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Hypoxemic Respiratory Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
RecruitingObservational study
Brain-lung Interaction During Acute Respiratory Failure
Acute Respiratory Failure
RecruitingPhase 2
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Acute Hypoxemic Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Villar study chair
Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypoxemic Respiratory Failure, run by Jesus Villar at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death in the intensive care unit (ICU) (time frame: up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.