Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients

NCT ID: NCT01095276

Last Updated: 2010-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2006-01-31

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.

Conditions

Atelectasis; Ventilation, Mechanical

Keywords

Mechanical Ventilation; Extubation; dornase alpha; oxygenation; chest x ray

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nebulized saline

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).

dornase alpha

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

Group Type: ACTIVE_COMPARATOR

Pulmozyme (nebulized dornase alpha)

Intervention Type: DRUG

nebulized dornase alpha: 2.5 mg by in-line nebulizer BID

Interventions

Pulmozyme (nebulized dornase alpha)

nebulized dornase alpha: 2.5 mg by in-line nebulizer BID

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Pulmozyme; DNase

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

University of Medicine and Dentistry of New Jersey

Principal Investigators

Jessica N Zitter, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UMDNJ, Department of Medicine

Locations

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, United States

Countries

United States

Other Identifiers

0120030304

Identifier Type: -

Identifier Source: org_study_id