View Clinical Trial (Medical Research Study)
Targeted Genomic Analysis of Coagulation Pathways in Acute Lung Injury
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94143 |
| Conditions: |
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Respiratory Distress Syndrome, Adult |
| Purpose: |
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Acute lung injury (ALI) is a severe lung condition that causes respiratory failure. This
study will examine if differences in genes involved in the blood clotting process may affect
the severity of and recovery from ALI in children hospitalized with the condition.
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| Study Summary: |
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ALI 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 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 DNA from
children with ALI to identify genetic variations that affect the blood clotting pathways.
This study will enroll children who are hospitalized with ALI. 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 use high throughput DNA sequencing technology to analyze
participants' DNA.
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| Criteria: |
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Inclusion Criteria:
- Hospitalized and requiring supplemental oxygen
- Meets the American-European consensus definition of ALI, 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
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| NCT ID: |
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NCT00605527 |
| Primary Contact: |
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Principal Investigator
Anil Sapru, MD, MAS
University of California, San Francisco
Anil Sapru, MD, MAS
Email: anil.sapru@ucsf.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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San Francisco, California 94143
United States
Anil Sapru, MD, MAS
Phone: 415-476-0963
Email: anil.sapru@ucsf.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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