Analysis of the Evolution of Mortality in an Intensive Care Unit

Respiratory Failure Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261607
• Other study ID #: Evolution mortality ICU
• Status: Recruiting
• Start date: July 1, 1991
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Hospital Universitario Getafe
• Contact: Fernando Frutos-Vivar, MD
• Phone: 346839360
• Email: fernando.frutos[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients admitted to intensive care unit

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Epidemiology
• Intensive Care Unit
• Mortality
• Nervous System Diseases
• Neurologic Disorder
• Respiration, Artificial
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Sepsis Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care Unit Mortality	Died during stay in the intensive care unit	180 days
Secondary	Hospital Mortality	Died during stay in the hospital	180 days
Secondary	Mortality 28-day	Mortality at day 28 after admission in the Hospital	28 days from date of admission in the Hospital
Secondary	Use of Mechanical ventilation	Proportion of patients who required mechanical ventilation (invasive and non-invasive) during stay in the intensive care unit	180 days
Secondary	Length of stay in the intensive care unit	Stay in the intensive care unit	180 days
Secondary	Length of stay in the hospital	Stay in the hospital	180 days
Secondary	Complications/events during stay in the intensive care unit	Rate of complications/events occurred in the intensive care unit	180 days