Status:
TERMINATED
Drug Study of Albuterol to Treat Acute Lung Injury
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
13+ years
Phase:
PHASE2
PHASE3
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 ...
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. Becau...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00434993
Start Date
August 1 2007
End Date
November 1 2008
Last Update
February 10 2017
Active Locations (40)
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1
University of San Francisco-Fresno Medical Center
Fresno, California, United States
2
University of California, Davis Medical Center
Sacramento, California, United States
3
UCSF-Moffitt Hospital
San Francisco, California, United States
4
UCSF-San Francisco General Hospital
San Francisco, California, United States