Understanding the Role of Genes in the Blood Clotting Process in Children With Acute Lung Injury - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00605527

Purpose

Acute lung injury (ALI) is a severe lung condition that causes respiratory failure. This study will examine if differences in genes involved in the blood clotting process may affect the severity of and recovery from ALI in children hospitalized with the condition.

Condition
Respiratory Distress Syndrome, Adult

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Targeted Genomic Analysis of Coagulation Pathways in Acute Lung Injury

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Biospecimen Description:

Blood and plasma samples will be analyzed

Estimated Enrollment:	315
Study Start Date:	November 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Detailed Description:

ALI 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 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 DNA from children with ALI to identify genetic variations that affect the blood clotting pathways.

This study will enroll children who are hospitalized with ALI. 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 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 with ALI.

Criteria

Inclusion Criteria:

Hospitalized and intubated
Meets the American-European consensus definition of ALI, 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

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

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
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Anil Sapru, MD, MAS 415-476-0963 anil.sapru@ucsf.edu

Sponsors and Collaborators

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 ( Anil Sapru, MD, MAS )
Study ID Numbers:	545, K23 HL085526-01A1
Study First Received:	January 18, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00605527
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Acute Lung Injury

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

ClinicalTrials.gov processed this record on January 14, 2009