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

NCT00671723 | Completed Results DMC

• 1 other identifier: 12783
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Keywords

Atelectasis

Outcome Measures

Primary Outcomes (1)

• Change in the Chest X-ray Atelectasis Score

  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.

  Baseline(Day 0) to Day 7

Secondary Outcomes (1)

• Rate of Extubation

  7 days

Study Arms (3)

Normal saline

PLACEBO COMPARATOR

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:

Hypertonic saline

ACTIVE COMPARATOR

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

Dornase alpha

ACTIVE COMPARATOR

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

Interventions

Normal saline: DRUG

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).

Also known as: Normal Saline

Normal saline

Hypertonic Saline DRUG

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).

Hypertonic saline

Dornase alpha DRUG

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).

Dornase alpha

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient on invasive mechanical ventilation
• New Onset (\<48 hours) lobar or multilobar lung atelectasis based on CXR

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Presbyterian Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Youness HA, Mathews K, Elya MK, Kinasewitz GT, Keddissi JI. Dornase alpha compared to hypertonic saline for lung atelectasis in critically ill patients. J Aerosol Med Pulm Drug Deliv. 2012 Dec;25(6):342-8. doi: 10.1089/jamp.2011.0954. Epub 2012 Mar 13.

  PMID: 22413805 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Saline Solution; Saline Solution, Hypertonic; dornase alfa

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hypertonic Solutions

Results Point of Contact

• Title: Dr. Houssein Youness
• Organization: University of Oklahoma Health Sciences Center

houssein-youness@ouhsc.edu

405-271-6173

Study Officials

• Jean Keddissi, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: October 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)