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

Study Description

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 Design


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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Number of ventilator-free days [ Time Frame: Measured during participant's hospital stay ]

Secondary Outcome Measures :

Mortality and organ dysfunction [ Time Frame: Measured during participant's hospital stay ]

Biospecimen Retention: Samples With DNA

Blood and plasma samples will be analyzed

Eligibility Criteria

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.

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

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 ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov 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

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