NCT05261607 Analysis of the Evolution of Mortality in an Intensive Care Unit
| NCT ID | NCT05261607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario Getafe |
| Condition | Intensive Care Unit |
| Study Type | OBSERVATIONAL |
| Enrollment | 25,000 participants |
| Start Date | 1991-07-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25,000 participants in total. It began in 1991-07-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: • Patients admitted to intensive care unit Exclusion Criteria: • None
Contact & Investigator
Fernando Frutos-Vivar, MD
PRINCIPAL INVESTIGATOR
Hospital Universitario de Getafe
Frequently Asked Questions
Who can join the NCT05261607 clinical trial?
This trial is open to participants of all sexes, studying Intensive Care Unit. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05261607 currently recruiting?
Yes, NCT05261607 is actively recruiting participants. Contact the research team at fernando.frutos@salud.madrid.org for enrollment information.
Where is the NCT05261607 trial being conducted?
This trial is being conducted at Getafe, Spain.
Who is sponsoring the NCT05261607 clinical trial?
NCT05261607 is sponsored by Hospital Universitario Getafe. The principal investigator is Fernando Frutos-Vivar, MD at Hospital Universitario de Getafe. The trial plans to enroll 25,000 participants.