Incidence of Acute Lung Injury: The Alien Study

Acute Lung Injury Clinical Trial

— ALIEN  

Official title:

Acute Lung Injury: Epidemiology and Natural History. The ALIEN Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736892
• Other study ID #: 2008-0915-EPI
• Status: Completed
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2018
• Source: Villar, Jesus, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Wounds and Injuries

Locations

Country	Name	City	State
Spain	Hospital Universitario Dr. Negrin	Las Palmas de Gran Canaria	Canary Islands

Sponsors (1)

Lead Sponsor	Collaborator
Villar, Jesus, M.D.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute lung injury and the acute respiratory distress syndrome		12 months
Secondary	Risk factor associated with acute lung injury		12 months
Secondary	Mortality rates of acute lung injury, acute respiratory distress syndrome and combined		12 months
Secondary	Identification of clinical data associated with the highest or lowest mortality		12 months