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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00605527
First received: January 18, 2008
Last updated: July 18, 2014
Last verified: July 2014
History of Changes
  Purpose

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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Number of ventilator-free days [ Time Frame: Measured during participant's hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality and organ dysfunction [ Time Frame: Measured during participant's hospital stay ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and plasma samples will be analyzed
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)
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.

  Eligibility
Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605527

Contacts
Contact: Anil Sapru, MD, MAS anil.sapru@ucsf.edu

Locations
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
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Anil Sapru, MD, MAS University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00605527     History of Changes
Other Study ID Numbers: 545, K23HL085526, K23 HL085526-01A1
Study First Received: January 18, 2008
Last Updated: July 18, 2014
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:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
 Lung Diseases
Lung Injury
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 01, 2015