Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients

University of Medicine and Dentistry of New Jersey

Status: Completed

Conditions: Ventilation, Mechanical; Atelectasis

Treatments: Drug: Pulmozyme (nebulized dornase alpha); Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01095276

0120030304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Nebulized saline

Placebo Comparator group

Description:

patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)

Treatment:

Drug: Saline

dornase alpha

Active Comparator group

Description:

patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization

Treatment:

Drug: Pulmozyme (nebulized dornase alpha)