Analysis of the Evolution of Mortality in an Intensive Care Unit

NCT05261607 | Recruiting

• 1 other identifier: Evolution mortality ICU
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Intensive care units; Outcome; Mortality

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit Mortality

  Died during stay in the intensive care unit

  180 days

Secondary Outcomes (6)

• Hospital Mortality

  180 days

• Mortality 28-day

  28 days from date of admission in the Hospital

• Use of Mechanical ventilation

  180 days

• Length of stay in the intensive care unit

  180 days

• Length of stay in the hospital

  180 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who required a admission to intensive care unit

You may qualify if:

• Patients admitted to intensive care unit

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration; Systemic Inflammatory Response Syndrome; Respiratory Insufficiency; Nervous System Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Shock

Study Officials

• Fernando Frutos-Vivar, MD

  Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Frutos-Vivar, MD

CONTACT

34916839360; fernando.frutos@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 2, 2022
• Study Start: July 1, 1991
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2023-03

Locations

ES (1)