Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients
This study has been completed.
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00671723
First received: April 30, 2008
Last updated: July 26, 2012
Last verified: July 2012
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Purpose
Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis.
We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.
| Condition | Intervention |
|---|---|
|
Atelectasis |
Drug: Normal saline: Drug: Hypertonic Saline Drug: Dornase alpha |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis |
Resource links provided by NLM:
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- Chest x-ray atelectasis score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PO2/FIO2, Mechanical ventilation days ICU days, [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 33 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Normal saline
Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
|
Drug: Normal saline:
Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Other Name: Normal Saline
|
|
Active Comparator: Hypertonic saline
Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
|
Drug: Hypertonic Saline
Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Other Name: Hypertonic Saline
|
|
Active Comparator: Dornase alpha
2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
|
Drug: Dornase alpha
2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Other Name: Dornase Alpha
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient on invasive mechanical ventilation
- New Onset (<48 hours) lobar or multilobar lung atelectasis based on CXR
Exclusion Criteria:
- Asthma
- Severe COPD (FEV1<30%)
- Pneumothorax or massive pleural effusion, thought to be causing the atelectasis
- Lobar atelectasis secondary to compressive tumor.
- Severe hypoxemia (PaO2/FiO2 < 75)
- Hemodynamic Instability
- Cystic fibrosis patients
- Allergy to DNase
- Patients on Acetylcysteine
- Pregnant women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671723
Locations
| United States, Oklahoma | |
| Presbyterian Hospital | |
| Oklahoma city, Oklahoma, United States, 73104 | |
Sponsors and Collaborators
University of Oklahoma
Investigators
| Principal Investigator: | Jean Keddissi, MD | University of Oklahoma |
More Information
No publications provided by University of Oklahoma
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00671723 History of Changes |
| Other Study ID Numbers: | 12783 |
| Study First Received: | April 30, 2008 |
| Last Updated: | July 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
Atelectasis |
Additional relevant MeSH terms:
|
Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013