Understanding the Role of Genes and Biomarkers in the Inflammation and Blood Clotting Process in … (NCT00605527) | Clinical Trial Compass
CompletedNot Applicable
Understanding the Role of Genes and Biomarkers in the Inflammation and Blood Clotting Process in Children With Acute Lung Injury
United States396 participantsStarted 2007-11
Plain-language summary
Acute lung injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) is a severe lung condition that causes respiratory failure. This study will examine if differences in genes and biomarkers involved in the inflammation and blood clotting process may affect the severity of and recovery from ALI/ARDS in children hospitalized with the condition.
Who can participate
Age range30 Days – 18 Years
SexALL
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Inclusion Criteria:
* Hospitalized and requiring supplemental oxygen
* Meets the American-European consensus definition of ALI/ARDS, defined as partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio of less than 300 mm Hg, bilateral opacities on a chest radiograph, and either a pulmonary wedge pressure of less than 18 mm Hg or the absence of clinical evidence of left atrial hypertension
* Acute pulmonary parenchymal disease (i.e., onset of bilateral infiltrates on chest radiograph within 48 hours of screening)
* PaO2/FiO2 less than or equal to 300 mm Hg, regardless of the mean airway pressure
* At least one arterial blood gas confirming partial pressure of oxygen/fraction of inspired oxygen (PO2/FiO2) ratio less than 300 mm Hg or Fi02/Sao2 on pulse oximetry of less than 320
Exclusion Criteria:
* Clinical signs of left ventricular failure, pulmonary capillary wedge pressure greater than 18 mm Hg, or evidence, such as echocardiography, suggesting a cardiac basis for the pulmonary edema
* Presence of right-to-left intracardiac shunt
What they're measuring
1
Number of ventilator-free days
Timeframe: Measured during participant's hospital stay