search
Back to results

Drug Study of Albuterol to Treat Acute Lung Injury (ALTA)

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Albuterol Sulfate
Mini-Bronchoalveolar Lavage (BAL)
Placebo
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Acute Lung Injury, Acute Respiratory Distress Syndrome, Albuterol, Aerosolized, Critical Care, Ventilator

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must meet the following three criteria within a 24-hour period:

    1. Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate)
    2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
    3. Requirement for positive pressure ventilation via endotracheal tube
  • No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates

Exclusion Criteria:

  • Greater than 48 hours since all inclusion criteria are met
  • Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis)
  • Pregnant or breast-feeding
  • Severe chronic respiratory disease (i.e., chronic hypercapnia [PaCO2 greater than 45 mmHg], chronic hypoxemia [PaO2 less than 55 mmHg on FiO2 = 0.21], hospitalization within the last 6 months for respiratory failure [PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2], secondary polycythemia, severe pulmonary hypertension [mean PAP (pulmonary artery pressure) greater than 40 mmHg], or ventilator dependency)
  • Burns over greater than 40% of total body surface area
  • Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  • Allogeneic bone marrow transplant within the 5 years prior to study entry
  • Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
  • Severe chronic liver disease (Child-Pugh score of 11-15)
  • Diffuse alveolar hemorrhage from vasculitis
  • Morbid obesity (greater than 1kg/cm body weight.)
  • Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol
  • Moribund participant and is not expected to survive 24 hours
  • No intent to obtain central venous access for monitoring intravascular pressures
  • Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information)
  • Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier
  • Unwillingness of primary physician to discontinue inpatient beta agonist use
  • Acute myocardial infarction or acute coronary syndrome within 30 days of study entry
  • Severe congestive heart failure (see Appendix A5 of the protocol for more information)
  • Participation in other experimental medication trial within 30 days of study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA)
  • Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age)
  • Currently receiving high frequency ventilation

Sites / Locations

  • University of San Francisco-Fresno Medical Center
  • University of California, Davis Medical Center
  • UCSF-Moffitt Hospital
  • UCSF-San Francisco General Hospital
  • Centura St. Anthony Central Hospital
  • Denver Health Medical Center
  • Rose Medical Center
  • University of Colorado Health Sciences Center
  • Washington Hospital Center
  • Baton Rouge General Hospital-Blue Bonnet
  • Baton Rouge General Hospital-Midcity
  • Earl K. Long Medical Center
  • Our Lady of the Lake Regional Medical Center
  • Medical Center of Louisiana
  • Ochsner Clinic Foundation
  • Tulane University Health Sciences Center
  • Baltimore VA Medical Center
  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Hospital
  • University of Maryland Shock Trauma Center
  • Baystate Medical Center
  • Rochester Methodist Hospital
  • St. Mary's Hospital, Mayo Clinic
  • University of North Carolina
  • Duke University Medical Center
  • Durham Regional Medical Center
  • Moses Cone Health System
  • Wesley Long Community Hospital
  • Wake Forest University Baptist Medical Center
  • Cleveland Clinic Foundation
  • MetroHealth Medical Center
  • University Hospitals of Cleveland
  • Vanderbilt University Medical Center
  • Baylor College of Medicine
  • McKay-Dee Hospital
  • Utah Valley Regional Medical Center
  • LDS Hospital
  • University of Virginia Medical Center
  • Harborview Medical Center
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Albuterol Sulfate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Ventilator Free Days (VFD)
Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.

Secondary Outcome Measures

Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60
Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.
Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90
Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.
Number of ICU-free Days at 28 Days After Randomization
ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.
Number of Organ Failure-free Days at Day 28 Following Randomization
Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.
Ventilator Free Days to Day 28 in the Subset of Participants With ARDS
Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.
Hospital Mortality to Day 60 in the Subset of Participants With ARDS
Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.
Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock
Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).
Hospital Mortality up to Day 60 in Subjects With Baseline Shock
Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).
Plasma Levels of IL-6 and IL-8 on Study Day 3
Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon's test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.

Full Information

First Posted
January 29, 2007
Last Updated
December 21, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00434993
Brief Title
Drug Study of Albuterol to Treat Acute Lung Injury
Acronym
ALTA
Official Title
Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Stopped for futility by DSMB
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.
Detailed Description
Aerosolized beta-2 agonist therapy is anticipated to diminish the formation of lung edema, enhance clearance of lung edema and decrease pulmonary inflammation in patients with acute lung injury. Because beta-2 agonists have been shown to reduce permeability induced lung injury, it is anticipated that the severity of lung injury will be reduced by aerosolized beta-2 agonist therapy. The therapy may work by enhancing resolution of pulmonary edema by upregulating alveolar epithelial fluid transport mechanisms that will in turn enhance the clearance of alveolar edema. A reduction in the severity of lung injury and the quantity of alveolar edema should result in earlier extubation and more ventilator free days, improved pulmonary oxygen uptake, and improved lung compliance. Study design: phase II/III prospective, randomized double-blind, placebo controlled trial. In Phase II, patients will be treated with aerosolized albuterol 5.0 mg vs. normal saline (n=40-50)administered every 4 hours for 10 days following randomization or until 24 hours following extubation, whichever occurs first. The protocol stipulates that the 5.0 mg dose will be reduced to 2.5 mg if patients exceed defined heart rate limits. In Phase III, the 5.0 mg dose will be used unless there is evidence that this dose has an unacceptable safety profile or dose reductions for tachycardia occur in a large fraction of patients. In that case, a lower dose of 2.5 mg will be used. Patients will be followed for 90 days or until discharge from the hospital to home with unassisted breathing whichever occurs first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
Acute Lung Injury, Acute Respiratory Distress Syndrome, Albuterol, Aerosolized, Critical Care, Ventilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albuterol Sulfate
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Albuterol Sulfate
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
Albuterol sulfate, USP, solution for inhalation will be diluted as follows: The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution. The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution. A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization. The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.
Intervention Type
Procedure
Intervention Name(s)
Mini-Bronchoalveolar Lavage (BAL)
Other Intervention Name(s)
Combicath
Intervention Description
The mini-BAL procedure involves blind specimen sampling from distal airspaces. Specimens are obtained with the Combicath (Plastimed) catheter. The procedure will be done on study days 0 and 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
Placebo aerosol will consist of 3.0 ml of identical appearing sterile 0.9 % sodium chloride without preservative. A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization (e.g.: throughout the inspiratory and expiratory cycle). The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.
Primary Outcome Measure Information:
Title
Number of Ventilator Free Days (VFD)
Description
Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.
Time Frame
Determined 28 days after a subject entered the study
Secondary Outcome Measure Information:
Title
Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60
Description
Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.
Time Frame
Determined 60 days after a subject entered the study
Title
Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90
Description
Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.
Time Frame
Determined 90 days after a subject entered the study
Title
Number of ICU-free Days at 28 Days After Randomization
Description
ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.
Time Frame
Determined 28 days after a subject entered the study
Title
Number of Organ Failure-free Days at Day 28 Following Randomization
Description
Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.
Time Frame
Daily from baseline to study day 28
Title
Ventilator Free Days to Day 28 in the Subset of Participants With ARDS
Description
Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.
Time Frame
Determined 28 days after a subject entered the study
Title
Hospital Mortality to Day 60 in the Subset of Participants With ARDS
Description
Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.
Time Frame
Determined 60 days after a subject entered the study
Title
Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock
Description
Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).
Time Frame
Determined 28 days after a subject entered the study
Title
Hospital Mortality up to Day 60 in Subjects With Baseline Shock
Description
Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).
Time Frame
Determined 60 days after a subject entered the study
Title
Plasma Levels of IL-6 and IL-8 on Study Day 3
Description
Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon's test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.
Time Frame
Measured at baseline and 3 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must meet the following three criteria within a 24-hour period: Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate) Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph Requirement for positive pressure ventilation via endotracheal tube No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates Exclusion Criteria: Greater than 48 hours since all inclusion criteria are met Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis) Pregnant or breast-feeding Severe chronic respiratory disease (i.e., chronic hypercapnia [PaCO2 greater than 45 mmHg], chronic hypoxemia [PaO2 less than 55 mmHg on FiO2 = 0.21], hospitalization within the last 6 months for respiratory failure [PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2], secondary polycythemia, severe pulmonary hypertension [mean PAP (pulmonary artery pressure) greater than 40 mmHg], or ventilator dependency) Burns over greater than 40% of total body surface area Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% Allogeneic bone marrow transplant within the 5 years prior to study entry Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest) Severe chronic liver disease (Child-Pugh score of 11-15) Diffuse alveolar hemorrhage from vasculitis Morbid obesity (greater than 1kg/cm body weight.) Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol Moribund participant and is not expected to survive 24 hours No intent to obtain central venous access for monitoring intravascular pressures Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information) Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier Unwillingness of primary physician to discontinue inpatient beta agonist use Acute myocardial infarction or acute coronary syndrome within 30 days of study entry Severe congestive heart failure (see Appendix A5 of the protocol for more information) Participation in other experimental medication trial within 30 days of study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA) Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age) Currently receiving high frequency ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Matthay, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roy Brower, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
University of San Francisco-Fresno Medical Center
City
Fresno
State/Province
California
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
UCSF-Moffitt Hospital
City
San Francisco
State/Province
California
Country
United States
Facility Name
UCSF-San Francisco General Hospital
City
San Francisco
State/Province
California
Country
United States
Facility Name
Centura St. Anthony Central Hospital
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Washington Hospital Center
City
Washington DC
State/Province
District of Columbia
Country
United States
Facility Name
Baton Rouge General Hospital-Blue Bonnet
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Baton Rouge General Hospital-Midcity
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Earl K. Long Medical Center
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Medical Center of Louisiana
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
University of Maryland Shock Trauma Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Rochester Methodist Hospital
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
St. Mary's Hospital, Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Durham Regional Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Moses Cone Health System
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Wesley Long Community Hospital
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
McKay-Dee Hospital
City
Ogden
State/Province
Utah
Country
United States
Facility Name
Utah Valley Regional Medical Center
City
Provo
State/Province
Utah
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
a deidentified database of the ALVEOLI study is available through BioLINCC
Citations:
PubMed Identifier
27440140
Citation
Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
Results Reference
derived
PubMed Identifier
26138630
Citation
Ambrus DB, Benjamin EJ, Bajwa EK, Hibbert KA, Walkey AJ. Risk factors and outcomes associated with new-onset atrial fibrillation during acute respiratory distress syndrome. J Crit Care. 2015 Oct;30(5):994-7. doi: 10.1016/j.jcrc.2015.06.003. Epub 2015 Jun 16. Erratum In: J Crit Care. 2015 Dec;30(6):1421.
Results Reference
derived
PubMed Identifier
21562125
Citation
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Matthay MA, Brower RG, Carson S, Douglas IS, Eisner M, Hite D, Holets S, Kallet RH, Liu KD, MacIntyre N, Moss M, Schoenfeld D, Steingrub J, Thompson BT. Randomized, placebo-controlled clinical trial of an aerosolized beta(2)-agonist for treatment of acute lung injury. Am J Respir Crit Care Med. 2011 Sep 1;184(5):561-8. doi: 10.1164/rccm.201012-2090OC.
Results Reference
derived
Links:
URL
http://www.ardsnet.org
Description
NHLBI Acute Respiratory Distress Syndrome Network Website
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/alta/
Available IPD/Information Identifier
ARDSNet-ALTA
Available IPD/Information Comments
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/alta/
Available IPD/Information Type
Study Forms
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/alta/

Learn more about this trial

Drug Study of Albuterol to Treat Acute Lung Injury

We'll reach out to this number within 24 hrs