Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atelectasis; Ventilation, Mechanical
Intervention: Pulmozyme (nebulized dornase alpha) (Drug); Saline (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Medicine and Dentistry of New Jersey Official(s) and/or principal investigator(s):
Jessica N Zitter, MD, MPH, Principal Investigator, Affiliation: UMDNJ, Department of Medicine
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.
Clinical Details
Official title: Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Total Chest X Ray Score
Secondary outcome: Oxygenation (Pa02/FI02)Static Lung Compliance Time to Extubation
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07183, United States
Additional Information
Starting date: November 2005
Last updated: March 29, 2010
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