Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients

Atelectasis Clinical Trial

Official title:

Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671723
• Other study ID #: 12783
• Status: Completed
• Phase: N/A
• First received: April 30, 2008
• Last updated: January 6, 2014
• Start date: October 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patient on invasive mechanical ventilation

2. New Onset (<48 hours) lobar or multilobar lung atelectasis based on CXR

Exclusion Criteria:

1. Asthma

2. Severe COPD (FEV1<30%)

3. Pneumothorax or massive pleural effusion, thought to be causing the atelectasis

4. Lobar atelectasis secondary to compressive tumor.

5. Severe hypoxemia (PaO2/FiO2 < 75)

6. Hemodynamic Instability

7. Cystic fibrosis patients

8. Allergy to DNase

9. Patients on Acetylcysteine

10. Pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Presbyterian Hospital	Oklahoma city	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest x-ray atelectasis score		7 days	No
Secondary	PO2/FIO2, Mechanical ventilation days ICU days,		7 days	Yes