Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 8:19 AM
Study NCT ID:
NCT01713595
Status:
WITHDRAWN
Last Update Posted:
2015-08-17
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Inhaled Saline in Acute Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011654', 'term': 'Pulmonary Edema'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055370', 'term': 'Lung Injury'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'difficult getting subjects', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Arterial Blood Gas Tension', 'timeFrame': 'Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery', 'description': 'Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.'}], 'primaryOutcomes': [{'measure': 'Dynamic Compliance of the Respiratory System', 'timeFrame': 'Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Patient-Ventilator Interactions', 'timeFrame': '5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery', 'description': '"Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Lung Injury', 'Mechanical Ventilation'], 'conditions': ['Pulmonary Edema']}, 'descriptionModule': {'briefSummary': 'To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).', 'detailedDescription': "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 ARDS 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study participants will include consenting adult patients (age \\> 18), who had been intubated and mechanically ventilated for \\<72 hours and meet international consensus criteria for ARDS.'}, 'identificationModule': {'nctId': 'NCT01713595', 'briefTitle': 'Safety Study of Inhaled Saline in Acute Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury', 'orgStudyIdInfo': {'id': '12-001723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertonic Saline Aerosol', 'description': 'a single 5ml dose of 7% Saline aerosol', 'interventionNames': ['Drug: Hypertonic Saline Aerosol']}], 'interventions': [{'name': 'Hypertonic Saline Aerosol', 'type': 'DRUG', 'otherNames': ['Nebulized hypertonic saline'], 'description': 'A single 5ml dose of 7% Saline aerosol', 'armGroupLabels': ['Hypertonic Saline Aerosol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard A Oeckler, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine and Physiology', 'investigatorFullName': 'Richard A. Oeckler, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}