Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
Primary Purpose
Atelectasis, Ventilation, Mechanical
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmozyme (nebulized dornase alpha)
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Atelectasis focused on measuring Mechanical Ventilation, Extubation, dornase alpha, oxygenation, chest x ray
Eligibility Criteria
Inclusion Criteria:
- current ventilator use
- onset of lobar or whole lung collapse over the previous 12 hours
- age greater than 18
Exclusion Criteria:
- quadriplegia or debilitating neuromuscular condition
- chronic ventilator dependence
- pneumothorax
- frank hemoptysis
- elevated intracranial pressure
- intracranial bleed
- pregnancy or active nursing
- concurrent use of other investigational drugs
- history of allergy to Pulmozyme®, Chinese Hamster Ovary-derived biologics, or any of the components of the active or placebo formulations.
Sites / Locations
- University of Medicine and Dentistry of New Jersey
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Nebulized saline
dornase alpha
Arm Description
patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization
Outcomes
Primary Outcome Measures
Total Chest X Ray Score
Secondary Outcome Measures
Oxygenation (Pa02/FI02)
Static Lung Compliance
Time to Extubation
Full Information
NCT ID
NCT01095276
First Posted
July 28, 2009
Last Updated
March 29, 2010
Sponsor
University of Medicine and Dentistry of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01095276
Brief Title
Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
Official Title
Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation.
Detailed Description
Background: Lobar or segmental collapse of the lung in mechanically ventilated patients is a relatively common occurrence in the Intensive Care Unit. Available treatments are either labor or time intensive and not highly effective.
Methods: We conducted a randomized, placebo-controlled, double-blind pilot study to determine whether nebulized recombinant human dornase alpha (Pulmozyme, Genentech) improves radiologic and clinical outcomes in ventilated patients with lobar atelectasis. Outcomes of interest were chest radiograph score, oxygenation, lung compliance, and rate of extubation over the first 5 days. The groups consisted of 14 intervention patients and 16 control patients. They were similar with respect to basic demographics, age, gender, and use of therapeutic modalities relating to lung function. Baseline average chest x-ray scores, Pa02/FI02 ratios, and static compliance were not significantly different. Analysis was limited to the first 5 days.
Results: There was a significant improvement in oxygenation for the intervention group at day 5 (p=0.03). There were no significant differences in chest radiograph score, compliance, or rate of extubation. Two patients died in the intervention group, whereas none died in the control group (NS).
Conclusions: These pilot data suggest that inhaled dornase alpha appears to be safe and is associated with improved oxygenation 5 days after initiation of therapy in mechanically ventilated patients compared to placebo. Larger studies are needed to confirm these findings and determine if this intervention decreases ICU morbidity and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Ventilation, Mechanical
Keywords
Mechanical Ventilation, Extubation, dornase alpha, oxygenation, chest x ray
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nebulized saline
Arm Type
Placebo Comparator
Arm Description
patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
Arm Title
dornase alpha
Arm Type
Active Comparator
Arm Description
patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization
Intervention Type
Drug
Intervention Name(s)
Pulmozyme (nebulized dornase alpha)
Other Intervention Name(s)
Pulmozyme, DNase
Intervention Description
nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).
Primary Outcome Measure Information:
Title
Total Chest X Ray Score
Time Frame
Days 0-30
Secondary Outcome Measure Information:
Title
Oxygenation (Pa02/FI02)
Time Frame
Days 0-30
Title
Static Lung Compliance
Time Frame
Days 0-30
Title
Time to Extubation
Time Frame
Days 0-30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
current ventilator use
onset of lobar or whole lung collapse over the previous 12 hours
age greater than 18
Exclusion Criteria:
quadriplegia or debilitating neuromuscular condition
chronic ventilator dependence
pneumothorax
frank hemoptysis
elevated intracranial pressure
intracranial bleed
pregnancy or active nursing
concurrent use of other investigational drugs
history of allergy to Pulmozyme®, Chinese Hamster Ovary-derived biologics, or any of the components of the active or placebo formulations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica N Zitter, MD, MPH
Organizational Affiliation
UMDNJ, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07183
Country
United States
12. IPD Sharing Statement
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Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
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