Phase 2
N=5
Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients
Octreotide · Sputum
Bottom Line
View on ClinicalTrials.gov: NCT02916433 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Bronchial Secretion Volume Over Preceding 24 Hour Period — 220; 310; 200; 70 mL/24 hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Octreotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Danbury Hospital
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bronchial Secretion Volume Over Preceding 24 Hour Period |
220; 310; 200; 70; 185; 185 | — |
| SECONDARY Extubation Within 72 Hours |
0; 50 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients are being weaned from mechanical ventilation
- Excessive bronchial secretions (over 200 ml/24 hours) is deemed by the Primary Team to be a major barrier to extubation
Exclusion Criteria
- Known hypersensitivity to octreotide
- Persistent bradycardia (HR < 60)
- Mobitz type II or 3rd degree heart block in patients without a pacemaker
- Patients being treated with intravenous agents for hypertensive urgency or emergency
- Surgical patients
- 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*
- 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
Data sourced from ClinicalTrials.gov (NCT02916433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.