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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • Hospital Universitario de Getafe

    Getafe, Madrid, 28905

Other trials in Spain

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

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.

  1. Intensive Care Unit Mortality

    Died during stay in the intensive care unit

    Measured: 180 days

Secondary outcomes (6)
  1. Hospital Mortality

    Died during stay in the hospital

    Measured: 180 days

  2. Mortality 28-day

    Mortality at day 28 after admission in the Hospital

    Measured: 28 days from date of admission in the Hospital

  3. 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

  4. Length of stay in the intensive care unit

    Stay in the intensive care unit

    Measured: 180 days

  5. Length of stay in the hospital

    Stay in the hospital

    Measured: 180 days

  6. 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.

  1. First posted2 Mar 2022
  2. Study start16 Jul 1991
  3. Primary completion16 Jul 2026
  4. Study completion31 Jul 2026

Resources

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)
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

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.

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