Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients

Not Applicable

Completed

• Conditions: Atelectasis; Ventilation, Mechanical
• Interventions: Drug: Saline; Drug: Pulmozyme (nebulized dornase alpha)

• Registration Number: NCT01095276
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2009-07-28
• Status Verified: 2010-03
• Study First Submitted QC: 2010-03-29
• Last Update Submitted: 2010-03-29
• Study First Posted: 2010-03-30
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• current ventilator use
• onset of lobar or whole lung collapse over the previous 12 hours
• age greater than 18

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized saline	Saline	patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
dornase alpha	Pulmozyme (nebulized dornase alpha)	patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization

Primary Outcome Measures

Name	Time	Method
Total Chest X Ray Score	Days 0-30

Secondary Outcome Measures

Name	Time	Method
Oxygenation (Pa02/FI02)	Days 0-30
Static Lung Compliance	Days 0-30
Time to Extubation	Days 0-30

Trial Locations

Locations (1)

University of Medicine and Dentistry of New Jersey; 🇺🇸 Newark, New Jersey, United States