Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00736892
Other study ID # 2008-0915-EPI
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04247477 - Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS N/A
Completed NCT03315702 - Effect of Mechanical Ventilation on Plasma Concentration Level of R-spondin Proteins
Not yet recruiting NCT02693912 - Changes in Alveolar Macrophage Function During Acute Lung Injury N/A
Completed NCT01659307 - The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury Phase 2
Unknown status NCT01186874 - Epidemiology Research on Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in Adult ICU in Shanghai N/A
Completed NCT01552070 - Recruitment on Extravascular Lung Water in Acute Respiratory Distress Syndrome (ARDS) Phase 2
Withdrawn NCT00961168 - Work of Breathing and Mechanical Ventilation in Acute Lung Injury N/A
Recruiting NCT00759590 - Comparison of Two Methods to Estimate the Lung Recruitment N/A
Completed NCT02475694 - Acute Lung Injury After Cardiac Surgery: Pathogenesis N/A
Completed NCT00825357 - Biological Markers to Identify Early Sepsis and Acute Lung Injury N/A
Terminated NCT00263146 - Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers. N/A
Completed NCT00188058 - Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome N/A
Completed NCT00234767 - Study of the Economics of Pulmonary Artery Catheter Use in Patients With Acute Respiratory Distress Syndrome (ARDS) Phase 3
Recruiting NCT02598648 - Role and Molecular Mechanism of Farnesoid X Receptor(FXR) and RIPK3 in the Formation of Acute Respiratory Distress Syndrome in Neonates N/A
Recruiting NCT02948530 - Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)
Completed NCT01532024 - Exploratory Clinical Study of Neutrophil Activation Probe (NAP) for Optical Molecular Imaging in Human Lungs Early Phase 1
Recruiting NCT01992237 - Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients N/A
Completed NCT01486342 - PET Imaging in Patients at Risk for Acute Lung Injury N/A
Withdrawn NCT01195428 - Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome (ALI/ARDS) N/A