|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT00671723 |
|
Date of registration:
|
30/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients
|
|
Scientific title:
|
Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis |
|
Date of first enrolment:
|
October 2006 |
|
Target sample size:
|
33 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00671723 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Jean Keddissi, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Oklahoma |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Atelectasis
|
|
Intervention(s)
|
|
Drug: Dornase alpha
|
|
Drug: Normal saline:
|
|
Drug: Hypertonic Saline
|
|
Primary Outcome(s)
|
|
Change in the Chest X-ray Atelectasis Score
[Time Frame: Baseline(Day 0) to Day 7]
|
|
Secondary Outcome(s)
|
|
Rate of Extubation
[Time Frame: 7 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|