Incidence of Acute Lung Injury: The Alien Study

NCT00736892 | Completed

• 1 other identifier: 2008-0915-EPI
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Acute lung injury is a clinical syndrome of rapid onset of acute respiratory failure. It represents a significant public health issue. Patients with acute lung injury require admission into critical care units for advanced life support and utilize considerable health care resources. Published epidemiological studies on acute lung injury in the last 20 years are difficult to compare because they used different definitions and length of time for evaluation. Less than five studies have collected information for an entire year, and none of them have evaluated the degree of oxygenation failure under standard settings. We will perform a one-year prospective audit of all patients admitted with acute lung injury in almost 40 ICUs in Spain.

Conditions

Acute Lung Injury

Keywords

Acute lung injury; Acute respiratory distress syndrome; Mechanical ventilation; Prognosis; Definitions

Outcome Measures

Primary Outcomes (1)

• Incidence of acute lung injury and the acute respiratory distress syndrome

  12 months

Secondary Outcomes (3)

• Risk factor associated with acute lung injury

  12 months

• Mortality rates of acute lung injury, acute respiratory distress syndrome and combined

  12 months

• Identification of clinical data associated with the highest or lowest mortality

  12 months

Study Arms (1)

A

All patients meeting the American European Consensus definition of acute lung injury will be included, regardless of etiology of respiratory failure. Specifically, all patients with rapid onset of acute lung injury not of cardiac origin (no indication of heart failure or a pulmonary capillary wedge pressure of greater than 18 mmHg, with pulmonary infiltrates in all four quadrants and a PaO2/FIO2 of \> 200 to \<300 mmHg or ≤ 200 mmHg.

Eligibility Criteria

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

Study Population

Patients admitted into intensive care units of participating hospitals across Spain meeting the American-European Consensus Conference definition of acute lung injury.

Sponsors & Collaborators

• Villar, Jesus, M.D.: lead

Study Sites (1)

Hospital Universitario Dr. Negrin

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

Location

Related Publications (4)

• Villar J, Gonzalez-Martin JM, Ambros A, Mosteiro F, Martinez D, Fernandez L, Soler JA, Parra L, Solano R, Soro M, Del Campo R, Gonzalez-Luengo RI, Civantos B, Montiel R, Pita-Garcia L, Vidal A, Anon JM, Ferrando C, Diaz-Dominguez FJ, Mora-Ordonez JM, Fernandez MM, Fernandez C, Fernandez RL, Rodriguez-Suarez P, Steyerberg EW, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score. Crit Care Med. 2021 Oct 1;49(10):e920-e930. doi: 10.1097/CCM.0000000000005142.

  PMID: 34259448 DERIVED

• Villar J, Ambros A, Mosteiro F, Martinez D, Fernandez L, Ferrando C, Carriedo D, Soler JA, Parrilla D, Hernandez M, Andaluz-Ojeda D, Anon JM, Vidal A, Gonzalez-Higueras E, Martin-Rodriguez C, Diaz-Lamas AM, Blanco J, Belda J, Diaz-Dominguez FJ, Rico-Feijoo J, Martin-Delgado C, Romera MA, Gonzalez-Martin JM, Fernandez RL, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials. Crit Care Med. 2019 Mar;47(3):377-385. doi: 10.1097/CCM.0000000000003624.

  PMID: 30624279 DERIVED

• Villar J, Martinez D, Mosteiro F, Ambros A, Anon JM, Ferrando C, Soler JA, Montiel R, Vidal A, Conesa-Cayuela LA, Blanco J, Arrojo R, Solano R, Capilla L, Del Campo R, Civantos B, Fernandez MM, Aldecoa C, Parra L, Gutierrez A, Martinez-Jimenez C, Gonzalez-Martin JM, Fernandez RL, Kacmarek RM; Stratification and Outcome of Acute Respiratory Distress Syndrome (STANDARDS) Network. Is Overall Mortality the Right Composite Endpoint in Clinical Trials of Acute Respiratory Distress Syndrome? Crit Care Med. 2018 Jun;46(6):892-899. doi: 10.1097/CCM.0000000000003022.

  PMID: 29420341 DERIVED

• Villar J, Blanco J, del Campo R, Andaluz-Ojeda D, Diaz-Dominguez FJ, Muriel A, Corcoles V, Suarez-Sipmann F, Tarancon C, Gonzalez-Higueras E, Lopez J, Blanch L, Perez-Mendez L, Fernandez RL, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification & Therapies for ARDS (SIESTA) Network. Assessment of PaO(2)/FiO(2) for stratification of patients with moderate and severe acute respiratory distress syndrome. BMJ Open. 2015 Mar 27;5(3):e006812. doi: 10.1136/bmjopen-2014-006812.

  PMID: 25818272 DERIVED

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jesus Villar, MD, PhD

  Hospital Universitario Dr. Negrin, Las Palmas, Spain

  PRINCIPAL INVESTIGATOR

• Robert M Kacmarek, PhD

  Massachusetts General Hospital, Boston, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

ES (1)