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Clinical Trials/NCT05261607
NCT05261607
Recruiting
Not Applicable

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

Hospital Universitario Getafe1 site in 1 country25,000 target enrollmentJuly 1, 1991

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Unit
Sponsor
Hospital Universitario Getafe
Enrollment
25000
Locations
1
Primary Endpoint
Intensive Care Unit Mortality
Status
Recruiting
Last Updated
last year

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
July 1, 1991
End Date
October 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Universitario Getafe
Responsible Party
Principal Investigator
Principal Investigator

Fernando Frutos-Vivar

Principal Investigator

Hospital Universitario Getafe

Eligibility Criteria

Inclusion Criteria

  • Patients admitted to intensive care unit

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intensive Care Unit Mortality

Time Frame: 180 days

Died during stay in the intensive care unit

Secondary Outcomes

  • Length of stay in the hospital(180 days)
  • Use of Mechanical ventilation(180 days)
  • Length of stay in the intensive care unit(180 days)
  • Mortality 28-day(28 days from date of admission in the Hospital)
  • Complications/events during stay in the intensive care unit(180 days)
  • Hospital Mortality(180 days)

Study Sites (1)

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