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

NCT00605527 | Completed

• 3 other identifiers: 545K23HL085526K23HL085526-01A1
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 5

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 inflammation and blood clotting process may affect the severity of and recovery from ALI/ARDS in children hospitalized with the condition.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute Lung Injury; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of ventilator-free days

  Measured during participant's hospital stay

Secondary Outcomes (1)

• Mortality and organ dysfunction

  Measured during participant's hospital stay

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Children's Hospital Central California

Fresno, California, 93710, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital & Research Center of Oakland

Oakland, California, 94609, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and plasma samples will be analyzed

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Anil Sapru, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

US (5)