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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
Sponsor:
Information provided by (Responsible Party):
Jesus Villar, Dr. Negrin University Hospital

Tracking Information
First Submitted Date August 15, 2008
First Posted Date August 18, 2008
Last Update Posted Date October 11, 2018
Actual Study Start Date September 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2008)
Incidence of acute lung injury and the acute respiratory distress syndrome [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 15, 2008)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence of Acute Lung Injury: The Alien Study
Official Title Acute Lung Injury: Epidemiology and Natural History. The ALIEN Study
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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Lung Injury
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 9, 2018)
300
Original Estimated Enrollment
 (submitted: August 15, 2008)
2000
Actual Study Completion Date May 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00736892
Other Study ID Numbers 2008-0915-EPI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jesus Villar, Dr. Negrin University Hospital
Study Sponsor Villar, Jesus, M.D.
Collaborators Not Provided
Investigators
Principal Investigator: Jesus Villar, MD, PhD Hospital Universitario Dr. Negrin, Las Palmas, Spain
Principal Investigator: Robert M Kacmarek, PhD Massachusetts General Hospital, Boston, USA
PRS Account Villar, Jesus, M.D.
Verification Date October 2018