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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease
Respiratory Distress Syndrome, Adult

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Targeted Genomic Analysis of Coagulation Pathways in Acute Lung Injury
Study Start Date : November 2007
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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

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

Biospecimen Retention:   Samples With DNA
Blood and plasma samples will be analyzed

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are admitted to the University of California, San Francisco hospital and participating sites including Children's Hospital of Oakland with ALI/ARDS.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00605527

Contact: Anil Sapru, MD, MAS

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   
Principal Investigator: Anil Sapru, MD         
United States, Wisconsin
American Family Children's Hospital Suspended
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Anil Sapru, MD, MAS University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT00605527     History of Changes
Other Study ID Numbers: 545
K23HL085526 ( U.S. NIH Grant/Contract )
K23HL085526-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

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
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries