Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients
|ClinicalTrials.gov Identifier: NCT01095276|
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Atelectasis Ventilation, Mechanical||Drug: Pulmozyme (nebulized dornase alpha) Drug: Saline||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
Placebo Comparator: Nebulized saline
patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).
Active Comparator: dornase alpha
patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization
Drug: Pulmozyme (nebulized dornase alpha)
nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
- Total Chest X Ray Score [ Time Frame: Days 0-30 ]
- Oxygenation (Pa02/FI02) [ Time Frame: Days 0-30 ]
- Static Lung Compliance [ Time Frame: Days 0-30 ]
- Time to Extubation [ Time Frame: Days 0-30 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095276
|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey|
|Newark, New Jersey, United States, 07183|
|Principal Investigator:||Jessica N Zitter, MD, MPH||UMDNJ, Department of Medicine|