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

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ClinicalTrials.gov Identifier: NCT00605527
Recruitment Status : Unknown
Verified October 2015 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : January 31, 2008
Last Update Posted : November 2, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

January 18, 2008
January 31, 2008
November 2, 2015
November 2007
December 2016   (Final data collection date for primary outcome measure)
Number of ventilator-free days [ Time Frame: Measured during participant's hospital stay ]
Same as current
Complete list of historical versions of study NCT00605527 on ClinicalTrials.gov Archive Site
Mortality and organ dysfunction [ Time Frame: Measured during participant's hospital stay ]
Same as current
Not Provided
Not Provided
 
Understanding the Role of Genes and Biomarkers in the Blood Clotting Process in Children With Acute Lung Injury
Targeted Genomic Analysis of Coagulation Pathways in Acute Lung Injury
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood and plasma samples will be analyzed
Non-Probability Sample
Patients who are admitted to the University of California, San Francisco hospital and participating sites including Children's Hospital of Oakland with ALI/ARDS.
Respiratory Distress Syndrome, Adult
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
450
315
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00605527
545
K23HL085526 ( U.S. NIH Grant/Contract )
K23HL085526-01A1 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Anil Sapru, MD, MAS University of California, San Francisco
University of California, San Francisco
October 2015