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CompletedNCT05261607Updated Sep 22, 2026

Analysis of the Evolution of Mortality in an Intensive Care Unit

An observational study in Intensive Care Unit, Mortality and Epidemiology, sponsored by Hospital Universitario Getafe. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Hospital Universitario Getafe · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
27,463
Sex
All
01

Study 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. 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

02

Conditions studied

  • Intensive Care Unit
  • Mortality
  • Epidemiology
  • Respiration, Artificial
  • Sepsis Syndrome
  • Respiratory Failure
  • Neurologic Disorder

Keywords

  • Intensive care units
  • Outcome
  • Mortality
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 27,463 is above the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Hospital Universitario Getafe is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who required a admission to intensive care unit

Inclusion criteria

  • Patients admitted to intensive care unit

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
27,463 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Intensive Care Unit Mortality

    Died during stay in the intensive care unit

    Time frame: 180 days

Secondary outcomes

  1. Hospital Mortality

    Died during stay in the hospital

    Time frame: 180 days

  2. Mortality 28-day

    Mortality at day 28 after admission in the Hospital

    Time frame: 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

    Time frame: 180 days

  4. Length of stay in the intensive care unit

    Stay in the intensive care unit

    Time frame: 180 days

  5. Length of stay in the hospital

    Stay in the hospital

    Time frame: 180 days

  6. Complications/events during stay in the intensive care unit

    Rate of complications/events occurred in the intensive care unit

    Time frame: 180 days

07

Study locations

1 site
  • Hospital Universitario de Getafe
    Getafe, Madrid 28905, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05261607
Lead sponsor
Hospital Universitario Getafe
Responsible party
Fernando Frutos-Vivar (Principal Investigator, Hospital Universitario Getafe) — Principal investigator
First posted
Mar 2, 2022
Start date
Jul 16, 1991
Primary completion
Jul 16, 2026
Completion
Jul 31, 2026
Last update
Sep 22, 2026

Study contacts

Fernando Frutos-Vivar, MD
principal investigator · Hospital Universitario de Getafe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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