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

Not Applicable

Completed

• Conditions: Atelectasis
• Interventions: Drug: Hypertonic Saline; Drug: Dornase alpha

• Registration Number: NCT00671723
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2014-02-06
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Results First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline	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	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).

Primary Outcome Measures

Name	Time	Method
Change in the Chest X-ray Atelectasis Score	Baseline(Day 0) to Day 7	Each CXR was assigned an atelectasis score.(\*) The absence or presence of contralateral hyperinflation was marked as 0 or 1 point, respectively. The absence or presence of mediastinal shift was scored as 0 or 1, respectively. Atelectasis was scored for each lobe. A partial atelectasis of one lobe was scored as one point, whereas complete atelectasis of a lobe was marked as two points. The distinction between infiltrate and atelectasis as well as the total scoring was done by the interpreting radiologist. These results were summed for each CXR. The score range from 0 to 10 with 0 indicates "no atelectasis",higher value indicates progressively more atelectasis.; \*Hendriks T, de Hoog M, Lequin MH, Devos AS, and Merkus PJ: DNase and atelectasis in non-cystic fibrosis pediatric patients. Crit Care. 2005;9:R351-R356.

Secondary Outcome Measures

Name	Time	Method
Rate of Extubation	7 days	percentage of patient who were extubated at day 7

Trial Locations

Locations (1)

Presbyterian Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States