Incidence of Acute Lung Injury: The Alien Study (ALIEN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jesus Villar, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier:
NCT00736892
First received: August 15, 2008
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition
Acute Lung Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Lung Injury: Epidemiology and Natural History. The ALIEN Study

Resource links provided by NLM:


Further study details as provided by Villar, Jesus, M.D.:

Primary Outcome Measures:
  • Incidence of acute lung injury and the acute respiratory distress syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk factor associated with acute lung injury [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mortality rates of acute lung injury, acute respiratory distress syndrome and combined [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Identification of clinical data associated with the highest or lowest mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736892

Locations
Spain
Hospital Universitario Dr. Negrin
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
Sponsors and Collaborators
Villar, Jesus, M.D.
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
  More Information

No publications provided

Responsible Party: Jesus Villar, Director of Research, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT00736892     History of Changes
Other Study ID Numbers: 2008-0915-EPI
Study First Received: August 15, 2008
Last Updated: September 13, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Villar, Jesus, M.D.:
Acute lung injury
Acute respiratory distress syndrome
Mechanical ventilation
Prognosis
Definitions

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014