Understanding the Role of Genes and Biomarkers in the Blood Clotting Process in Children With Acute Lung Injury (PALI)
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Purpose
| Condition |
|---|
|
Respiratory Distress Syndrome, Adult |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Targeted Genomic Analysis of Coagulation Pathways in Acute Lung Injury |
- Number of ventilator-free days [ Time Frame: Measured during participant's hospital stay ] [ Designated as safety issue: No ]
- Mortality and organ dysfunction [ Time Frame: Measured during participant's hospital stay ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00605527
| Contact: Anil Sapru, MD, MAS | anil.sapru@ucsf.edu |
| United States, California | |
| Children's Hospital Central California | Suspended |
| Fresno, California, United States, 93710 | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Robinder Khemani, MD 323-361-2557 | |
| Principal Investigator: Robinder Khemani, MD | |
| Children's Hospital & Research Center of Oakland | Suspended |
| Oakland, California, United States, 94609 | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Anil Sapru, MD, MAS 415-476-0963 anil.sapru@ucsf.edu | |
| Principal Investigator: Anil Sapru, MD | |
| United States, Wisconsin | |
| American Family Children's Hospital | Suspended |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | Anil Sapru, MD, MAS | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00605527 History of Changes |
| Other Study ID Numbers: | 545 K23HL085526 K23HL085526-01A1 |
| Study First Received: | January 18, 2008 |
| Last Updated: | October 30, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
Acute Lung Injury Acute Respiratory Distress Syndrome |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Respiratory Tract Diseases Lung Injury Lung Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on September 28, 2016