Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atelectasis Ventilation, Mechanical |
Drug: Pulmozyme (nebulized dornase alpha) Drug: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients |
- Total Chest X Ray Score [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
- Oxygenation (Pa02/FI02) [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
- Static Lung Compliance [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
- Time to Extubation [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | November 2005 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Nebulized saline
patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
|
Drug: Saline
Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).
|
|
Active Comparator: dornase alpha
patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization
|
Drug: Pulmozyme (nebulized dornase alpha)
nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07183 | |
| Principal Investigator: | Jessica N Zitter, MD, MPH | UMDNJ, Department of Medicine |
More Information
No publications provided
| Responsible Party: | Jessica Nutik Zitter, MD, MPH, University of Medicine and Dentistry of New Jersey |
| ClinicalTrials.gov Identifier: | NCT01095276 History of Changes |
| Other Study ID Numbers: | 0120030304 |
| Study First Received: | July 28, 2009 |
| Last Updated: | March 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
Mechanical Ventilation Extubation dornase alpha oxygenation chest x ray |
Additional relevant MeSH terms:
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Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013