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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00671723
Other study ID # 12783
Secondary ID
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


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
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