Incidence of Acute Lung Injury: The Alien Study (ALIEN)
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|ClinicalTrials.gov Identifier: NCT00736892|
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : October 11, 2018
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|Condition or disease|
|Acute Lung Injury|
Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute respiratory distress syndrome (ARDS). It represents a significant public health issue. Patients with ALI or ARDS require admission into critical care units for advanced life support and utilize considerable health care resources.
An immense plethora of translational knowledge has been acquired since the first description of ARDS in 1967. However, estimates of the incidence of ARDS and ALI have varied widely, and the true magnitude of this health problem still remains unclear. Current estimates of the incidence of ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in Spain. Combined mortality rates for ALI/ARDS range between 30-45%. ALI and ARDS occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma.
Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to compare. Some reports have used different definitions for ALI and ARDS and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. Very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J Respir Crit Care Med 2007; 176:795-804).
As a result, we propose to perform a one-year prospective audit of all ALI and ARDS patients managed in 40 ICUs from 17 Spanish provinces (15 provinces in the mainland and 2 provinces in the Canary Islands). We intend to collect data from all patients admitted with or developing ALI/ARDS with the aim to understand the epidemiology and natural history of acute lung injury. These provinces are scattered through the Spain and are representative of the demographic differences across the country.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Acute Lung Injury: Epidemiology and Natural History. The ALIEN Study|
|Actual Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||May 2010|
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.
- Incidence of acute lung injury and the acute respiratory distress syndrome [ Time Frame: 12 months ]
- Risk factor associated with acute lung injury [ Time Frame: 12 months ]
- Mortality rates of acute lung injury, acute respiratory distress syndrome and combined [ Time Frame: 12 months ]
- Identification of clinical data associated with the highest or lowest mortality [ Time Frame: 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Inclusion Criteria:American-European Consensus Conference Definition criteria for acute lung injury:(i) rapid onset of acute lung injury not of cardiac origin; (ii) bilateral pulmonary infiltrates on chest X ray; (iii) PaO2/FIO2<300 mmHg.
Exclusion Criteria: None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736892
|Hospital Universitario Dr. Negrin|
|Las Palmas de Gran Canaria, Canary Islands, Spain, 35010|
|Principal Investigator:||Jesus Villar, MD, PhD||Hospital Universitario Dr. Negrin, Las Palmas, Spain|
|Principal Investigator:||Robert M Kacmarek, PhD||Massachusetts General Hospital, Boston, USA|
|Responsible Party:||Jesus Villar, Director of Research, Dr. Negrin University Hospital|
|Other Study ID Numbers:||
|First Posted:||August 18, 2008 Key Record Dates|
|Last Update Posted:||October 11, 2018|
|Last Verified:||October 2018|
Acute lung injury
Acute respiratory distress syndrome
Acute Lung Injury
Wounds and Injuries
Respiratory Tract Diseases