Understanding the Role of Genes and Biomarkers in the Inflammation and Blood Clotting Process in Children With Acute Lung Injury

Completed

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT00605527

Run by

University of California, San Francisco

People needed

396

Starts

2007-11-01

Expected to finish

2016-12-01

Last updated by the study team

2020-07-20

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Central California — Fresno, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital & Research Center of Oakland — Oakland, California, United States
• University of California, San Francisco — San Francisco, California, United States
• American Family Children's Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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