Safety Study of Inhaled Saline in Acute Lung Injury
This study is currently recruiting participants.
Verified October 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Rolf D. Hubmayr, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01713595
First received: October 4, 2012
Last updated: October 24, 2012
Last verified: October 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 4, 2012 | ||||||||
| Last Updated Date | October 24, 2012 | ||||||||
| Start Date ICMJE | October 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Dynamic Compliance of the Respiratory System [ Time Frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery ] [ Designated as safety issue: Yes ] Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01713595 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Patient-Ventilator Interactions [ Time Frame: 5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery ] [ Designated as safety issue: Yes ] "Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
Arterial Blood Gas Tension [ Time Frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery ] [ Designated as safety issue: Yes ] Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety Study of Inhaled Saline in Acute Lung Injury | ||||||||
| Official Title ICMJE | Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury | ||||||||
| Brief Summary | To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute lung injury [ALI]. |
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| Detailed Description | Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ALI center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Pulmonary Edema | ||||||||
| Intervention ICMJE | Drug: Hypertonic Saline Aerosol
a single 5ml dose of 7% Saline aerosol |
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| Study Arm (s) | Experimental: Hypertonic Saline Aerosol
a single 5ml dose of 7% Saline aerosol
Intervention: Drug: Hypertonic Saline Aerosol |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01713595 | ||||||||
| Other Study ID Numbers ICMJE | 12-001723 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Rolf D. Hubmayr, Mayo Clinic | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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