Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sputum; Octreotide
• Intervention / Treatment: Drug: Octreotide

Detailed Description

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.

The 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.

This 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.

Primary outcome: Change in the rate of bronchial secretion, as compared to the baseline.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; This group will continue to receive treatments that have already been initiated to manage bronchial secretions.
Experimental: Octreotide; This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.	Drug: Octreotide; Other Names: Sandostatin LAR; Sandostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchial Secretion Volume Over Preceding 24 Hour Period	Change in the rate of bronchial secretion at 24, 48, and 72 hours post-intervention initiation, as compared to the baseline rate	baseline, 24, 48, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation Within 72 Hours	Percentage of patients who were extubated within 72 hours of intervention initiation	72 hours

Collaborators and Investigators

• Sponsor: Danbury Hospital
• Investigators: Principal Investigator: Abhijith Hegde, MD, Danbury Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: 16-1101