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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Targeted Genomic Analysis of Coagulation Pathways in Acute Lung Injury

Brief 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 blood clotting process may affect the severity of and recovery from ALI/ARDS in children hospitalized with the condition.

Detailed Summary:

ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, which leads to low blood oxygen levels and respiratory failure. Common causes include pneumonia, sepsis, and lung trauma. Symptoms, including breathing difficulty, low blood pressure, and organ failure, usually develop within 24 to 48 hours of the original injury or illness. Most patients require immediate care in an intensive care unit, and the main form of treatment is mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. Although progress has been made in understanding how ALI/ARDS develops, it is still unknown why recovery outcomes differ among people. Differences in the genetic basis of protein C and fibrinolysis pathways, which both play a role in preventing blood clots, may be a factor in determining the severity of and recovery from ALI. The purpose of this study is to analyze plasma and DNA from children with ALI/ARDS to identify biomarkers and genetic variations that may be related to clinical outcomes.

This study will enroll children who are hospitalized with ALI/ARDS. Participants' medical records will be reviewed to gather information about symptoms, physical exam findings, mechanical ventilator settings, and laboratory test results. A blood collection will occur on Days 1 and 3. Study researchers will analyze plasma biomarkers and use high throughput DNA sequencing technology to analyze participants' DNA.

Sponsor: University of California, San Francisco

Current Primary Outcome: Number of ventilator-free days [ Time Frame: Measured during participant's hospital stay ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mortality and organ dysfunction [ Time Frame: Measured during participant's hospital stay ]

Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: January 18, 2008
Date Started: November 2007
Date Completion: December 2016
Last Updated: October 30, 2015
Last Verified: October 2015