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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

Page last updated: August 23, 2015

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