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NCT Number: NCT05261607

Analysis of the Evolution of Mortality in an Intensive Care Unit

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted to intensive care unit

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Intensive Care Unit Mortality

    Time frame: 180 days

    Died during stay in the intensive care unit

Secondary outcomes

  1. Hospital Mortality

    Time frame: 180 days

    Died during stay in the hospital

  2. Mortality 28-day

    Time frame: 28 days from date of admission in the Hospital

    Mortality at day 28 after admission in the Hospital

  3. Use of Mechanical ventilation

    Time frame: 180 days

    Proportion of patients who required mechanical ventilation (invasive and non-invasive) during stay in the intensive care unit

  4. Length of stay in the intensive care unit

    Time frame: 180 days

    Stay in the intensive care unit

  5. Length of stay in the hospital

    Time frame: 180 days

    Stay in the hospital

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

    Time frame: 180 days

    Rate of complications/events occurred in the intensive care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Frutos-Vivar, MD

CONTACT

[email protected]

34916839360 ext. 462766

Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Official study title

Epidemiological Analysis of the Evolution of the Case-mix and Mortality in the Intensive Care Unit of Hospital Universitario De Getafe (1991-2026)

Important dates

Study start
1991
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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