Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT02916433
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Joann.Petrini@wchn.org', 'phone': '203-739-6882', 'title': 'Joann Petrini', 'organization': 'Western Connecticut Health Network'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Investigators were only able to enroll 5 patients in 2 years, therefore, study was terminated early.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up to 72 hours per subject', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Octreotide', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bronchial Secretion Volume Over Preceding 24 Hour Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'This patient have received treatments that have already been initiated to manage bronchial secretions. Below are the bronchial secretion rate at 24, 48, 72 hours.'}, {'id': 'OG001', 'title': 'Octreotide #1', 'description': 'This patient have received treatments that have already been initiated to manage bronchial secretions. Additionally, this patient received parenteral octreotide. Below are the bronchial secretion rate at 24, 48, 72 hours.'}, {'id': 'OG002', 'title': 'Octreotide #2', 'description': 'This patient have received treatments that have already been initiated to manage bronchial secretions. Additionally, this patient received parenteral octreotide. Below are the bronchial secretion rate at 24, 48, 72 hours.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}]}, {'title': '24 hr time point', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}]}, {'title': '48 hr time point', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': '72 hr time point', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Patient discharged before this time point', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, 24, 48, 72 hours', 'description': 'Change in the rate of bronchial secretion at 24, 48, and 72 hours post-intervention initiation, as compared to the baseline rate', 'unitOfMeasure': 'mL/24 hr', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Extubation Within 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions.'}, {'id': 'OG001', 'title': 'Octreotide', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Percentage of patients who were extubated within 72 hours of intervention initiation', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions.'}, {'id': 'FG001', 'title': 'Octreotide', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.\n\nOctreotide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions.'}, {'id': 'BG001', 'title': 'Octreotide', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': 'NA', 'comment': 'the standard deviation is a measure of the amount of variation and here we have data from only one participant', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '61', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-08', 'size': 268353, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-24T23:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2016-09-26', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-27', 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchial Secretion Volume Over Preceding 24 Hour Period', 'timeFrame': 'baseline, 24, 48, 72 hours', 'description': 'Change in the rate of bronchial secretion at 24, 48, and 72 hours post-intervention initiation, as compared to the baseline rate'}], 'secondaryOutcomes': [{'measure': 'Extubation Within 72 Hours', 'timeFrame': '72 hours', 'description': 'Percentage of patients who were extubated within 72 hours of intervention initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Octreotide', 'Sputum']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether administration of octreotide (12-25 mcg/hour) for 72 hours in combination with the standard of care treatment is effective in reducing bronchorrhea (excessive airway secretions) in mechanically ventilated patients. The use of this drug (octreotide) to manage bronchorrhea has not been approved by the United States Food and Drug Administration (FDA) and is used as an experimental drug in this research study. We are anticipating to enroll approximately 30 subjects in this study at Danbury Hospital, with 15 patients randomly assigned to the "Routine Care" group, which will serve as the control group, and 15 patients randomly assigned to the octreotide group. Control group will only receive the standard of care and will not receive this drug. Total subject participation in this study will be for 4 days (96 hours) or until their breathing tube is removed (extubation), whichever occurs first.', 'detailedDescription': 'Octreotide is widely available and has a relatively low cost (about $17/day in our hospital). In the United States, it has been used widely in outpatient and inpatient settings for over 16 years, mostly for various endocrinopathies and gastrointestinal variceal bleeds but also for a number of other pathologies. It is considered by clinicians to be an overall well-tolerated medication, with fewer significant side-effects compared to systemic steroids and scopolamine. If octreotide is proven to be an effective mucoregulator, it may become an essential tool used in the intensive care units throughout the world.\n\nThe purpose of this study is to evaluate effectiveness of including parenteral octreotide (12-25 mcg/hour for 72 hours) in addition to the other standard of care treatments deemed necessary by the ICU attending physician in managing bronchorrhea in mechanically ventilated patients. It is hypothesized that octreotide decreases excessive bronchial secretions and shortens time to extubation.\n\nThis study is an open-label, randomized controlled trial. Patients will be randomized into two groups of 15, "Routine Care" group, which will serve as the control group, and "Octreotide" group. The amount of bronchial secretions is routinely measured in all mechanically ventilated patients. Once the Primary Team identifies a patient as a candidate for the study (based on the inclusion and exclusion criteria) and an informed consent has been obtained, the baseline volume of bronchial secretions per 12-hour period will be recorded and a security envelope containing group assignment will be opened by the ICU attending. Both groups will continue to receive treatments that have already been initiated to manage bronchial secretions. In addition, "Octreotide" group will receive parenteral octreotide, while "Routine Care" group will receive care as deemed necessary by the Primary Team. The rate of bronchial secretions will be measured and recorded daily; the changes, relative to the baseline measurements, will be compared between the groups. These interventions will be continued for 72 hours or until extubation or withdrawal from the study, whichever occurs earlier. Subsequently, the standard of care management, as determined by the Primary Team, will be resumed.\n\nPrimary outcome: Change in the rate of bronchial secretion, as compared to the baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are being weaned from mechanical ventilation\n* Excessive bronchial secretions (over 200 ml/24 hours) is deemed by the Primary Team to be a major barrier to extubation\n\nExclusion Criteria:\n\n* Known hypersensitivity to octreotide\n* Persistent bradycardia (HR \\< 60)\n* Mobitz type II or 3rd degree heart block in patients without a pacemaker\n* Patients being treated with intravenous agents for hypertensive urgency or emergency\n* Surgical patients\n* Initiation of therapy with systemic or inhaled steroids within 72 hours prior to the enrollment into the study, as these may further change the rate of secretions\\*\n* Initiation of therapy with systemic or inhaled anticholinergics within 48 hours prior to the enrollment into the study, as these may further change the rate of secretions'}, 'identificationModule': {'nctId': 'NCT02916433', 'briefTitle': 'Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Danbury Hospital'}, 'officialTitle': 'Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '16-1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions.'}, {'type': 'EXPERIMENTAL', 'label': 'Octreotide', 'description': 'This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.', 'interventionNames': ['Drug: Octreotide']}], 'interventions': [{'name': 'Octreotide', 'type': 'DRUG', 'otherNames': ['Sandostatin', 'Sandostatin LAR'], 'armGroupLabels': ['Octreotide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Hospital', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}], 'overallOfficials': [{'name': 'Abhijith Hegde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danbury Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danbury Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Outcomes and Health Services Research', 'investigatorFullName': 'Joann Petrini, PhD, MPH', 'investigatorAffiliation': 'Danbury Hospital'}}}}