Clinical Trial: Incidence of Acute Lung Injury: The Alien Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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 Summary:
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
Sponsor: Villar, Jesus, M.D.
Current Primary Outcome: Incidence of acute lung injury and the acute respiratory distress syndrome [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Villar, Jesus, M.D.
Dates:
Date Received: August 15, 2008
Date Started: September 2008
Date Completion:
Last Updated: September 13, 2012
Last Verified: September 2012
