NCT00217880

Brief Summary

The purpose of this study is to identify biological markers of disease in patients with acute lung injury (ALI) that are predictive of either disease susceptibility or prognosis, or that identify novel targets of therapeutic intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 19, 2013

Status Verified

July 1, 2009

Enrollment Period

4.8 years

First QC Date

September 19, 2005

Last Update Submit

August 16, 2013

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (4)

  • PaO2/FiO2 ratios

    Measured at Year 4

  • Lung compliance

    Measured at Year 4

  • Plateau pressures

    Measured at Year 4

  • Calculation of the Murray Lung Injury Score (obtained at entry and Days 1, 2, 3, 5, 7,10, 14, and 21; analyzed at Year 4)

    Measured at Year 4

Secondary Outcomes (8)

  • Development of organ failure

    Measured at Year 4

  • Time on ventilator

    Measured at Year 4

  • Ventilator-free days

    Measured at Year 4

  • ICU and hospital length of stay

    Measured at Year 4

  • Hospital mortality

    Measured at Year 4

  • +3 more secondary outcomes

Interventions

BronchoscopyPROCEDURE

A bronchoscopy test will occur to view the participant's airways.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute onset of illness with:
  • PaO2/FiO2 ratio of less than 300 (ALI) or PaO2/FiO2 ratio of less than 200 (ARDS)
  • Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
  • Positive pressure ventilation via an endotracheal tube
  • No clinical evidence of left atrial hypertension (if measured, pulmonary arterial wedge pressure less than or equal to 18 mm Hg)
  • First three criteria must occur together within a 24-hour interval

You may not qualify if:

  • Greater than 48 hours elapsed following institution of mechanical ventilation
  • Pregnancy
  • Chronic respiratory failure as defined by any of the following:
  • FEV1 less than 20 ml/kg of PBW; FEV1/FVC less than 50%
  • Chronic hypercapnia or hypoxemia
  • Hospitalization within past 6 months for acute respiratory failure
  • Chronic home use of oxygen or mechanical ventilation
  • Left ventricular failure as defined by New York Heart Association (NYHA) class IV status
  • History of hematological malignancy or bone marrow transplantation
  • Entry in other intervention clinical trials
  • Decision of the patient or attending physician to forego aggressive care
  • Expected survival of less than 6 months (based solely on pre-existing medical problems \[e.g., poorly controlled neoplasm or other end-stage disease\])
  • AIDS (known history of HIV infection)
  • Prednisone (or equivalent) therapy of 20 mg/day or more for a period of at least 2 months with treatment continuing within 3 weeks prior to screening
  • Cytotoxic therapy within 3 weeks of screening
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Theodore J. Standiford, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

July 1, 2004

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

August 19, 2013

Record last verified: 2009-07

Locations

US(2)