Intensive Care UnitNCT05261607
Analysis of the Evolution of Mortality in an Intensive Care Unit
An observational study of Intensive Care Unit and Mortality, run by Hospital Universitario Getafe at 1 site in Spain.
Trial summary
The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Unit, Mortality, Epidemiology
- How many people
- 27,463 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jul 1991to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who required a admission to intensive care unit
Who may be able to join
- Patients admitted to intensive care unit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Analysis of the Evolution of the Case-mix and Mortality in the Intensive Care Unit of Hospital Universitario de Getafe (1991-2026)
The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment.
Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU.
Read more
Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients.
That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit.
Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026
- Conditions
- Intensive Care Unit, Mortality, Epidemiology, Respiration, Artificial, Sepsis Syndrome, Respiratory Failure
- Keywords
- Intensive care units, Outcome, Mortality
- Medical subject headings
- Respiratory Aspiration, Systemic Inflammatory Response Syndrome, Respiratory Insufficiency, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Unit Mortality
Died during stay in the intensive care unit
Measured: 180 days
Secondary outcomes (6)
Hospital Mortality
Died during stay in the hospital
Measured: 180 days
Mortality 28-day
Mortality at day 28 after admission in the Hospital
Measured: 28 days from date of admission in the Hospital
Use of Mechanical ventilation
Proportion of patients who required mechanical ventilation (invasive and non-invasive) during stay in the intensive care unit
Measured: 180 days
Length of stay in the intensive care unit
Stay in the intensive care unit
Measured: 180 days
Length of stay in the hospital
Stay in the hospital
Measured: 180 days
Complications/events during stay in the intensive care unit
Rate of complications/events occurred in the intensive care unit
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start16 Jul 1991
- Primary completion16 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies 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
- Retrospective
- Enrolment
- 27,463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Frutos-Vivar, Hospital Universitario Getafe
- Investigators
- Fernando Frutos-Vivar, MD, Principal investigator, Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261607
- Sponsor's protocol ID
- Evolution mortality ICU
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Analysis of the Evolution of the Case-mix and Mortality in the Intensive Care Unit of Hospital Universitario de Getafe (1991-2026)
- ClinicalTrials.gov ID
- NCT05261607
- Acronym / sponsor ID
- Evolution mortality ICU
- Conditions
- Intensive Care Unit, Mortality, Epidemiology, Respiration, Artificial, Sepsis Syndrome, Respiratory Failure
- Keywords
- Intensive care units, Outcome, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,463 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- 16 Jul 1991 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 2 Mar 2022 (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.
The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment.
Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU.
Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients.
That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit.
Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who required a admission to intensive care unit
Key inclusion criteria (1 listed)
- Patients admitted to intensive care unit
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intensive Care Unit Mortality
Time frame: 180 days
Died during stay in the intensive care unit
6 secondary outcomes
Hospital Mortality
Time frame: 180 days
Mortality 28-day
Time frame: 28 days from date of admission in the Hospital
Use of Mechanical ventilation
Time frame: 180 days
Length of stay in the intensive care unit
Time frame: 180 days
Length of stay in the hospital
Time frame: 180 days
Complications/events during stay in the intensive care unit
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Fernando Frutos-Vivar, MD principal investigator
Hospital Universitario de Getafe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Mortality, run by Hospital Universitario Getafe at 1 site in Spain.
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: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensive Care Unit Mortality (time frame: 180 days). 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 22 Sep 2026.