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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05261607
Other study ID # Evolution mortality ICU
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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