Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

• Sponsor: Danbury Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02916433
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 29
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Octreotide; Sputum	Drug: Octreotide	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients: A Randomized Controlled Trial
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

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 Sandostatin LAR

Outcome Measures

Primary Outcome Measures

1. Bronchial Secretion Volume Over Preceding 24 Hour Period [baseline, 24, 48, 72 hours]

   Change in the rate of bronchial secretion at 24, 48, and 72 hours post-intervention initiation, as compared to the baseline rate

Secondary Outcome Measures

1. Extubation Within 72 Hours [72 hours]

   Percentage of patients who were extubated within 72 hours of intervention initiation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danbury Hospital	Danbury	Connecticut	United States	06810

Sponsors and Collaborators

• Danbury Hospital

Investigators

• Principal Investigator: Abhijith Hegde, MD, Danbury Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2017

More Information

Publications

None provided.

• Responsible Party: Joann Petrini, PhD, MPH, Director, Clinical Outcomes and Health Services Research, Danbury Hospital
• ClinicalTrials.gov Identifier: NCT02916433
• Other Study ID Numbers: 16-1101
• First Posted: Sep 27, 2016
• Last Update Posted: Oct 8, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Octreotide

Study Results

Participant Flow

Arm/Group Title	Usual Care	Octreotide
Arm/Group Description	This group will continue to receive treatments that have already been initiated to manage bronchial secretions.	This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide. Octreotide
Period Title: Overall Study
STARTED	3	2
COMPLETED	1	2
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Usual Care	Octreotide	Total
Arm/Group Description	This group will continue to receive treatments that have already been initiated to manage bronchial secretions.	This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.	Total of all reporting groups
Overall Participants	1	2	3
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (NA)	59.5 (2.1)	61 (3)
Sex: Female, Male (Count of Participants)
Female	1 100%	0 0%	1 33.3%
Male	0 0%	2 100%	2 66.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Octreotide #1	Octreotide #2
Arm/Group 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.	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.	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.
Measure Participants	1	1	1
Baseline	220	310	200
24 hr time point	70	185	185
48 hr time point	195	120	170
72 hr time point	25	NA	140

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Octreotide
Arm/Group Description	This group will continue to receive treatments that have already been initiated to manage bronchial secretions.	This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.
Measure Participants	1	2
Number [percentage of patients]	0	50

Adverse Events

Time Frame	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
Arm/Group Title	Usual Care		Octreotide
Arm/Group Description	This group will continue to receive treatments that have already been initiated to manage bronchial secretions.		This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.
All Cause Mortality
	Usual Care		Octreotide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)
Serious Adverse Events
	Usual Care		Octreotide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		Octreotide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)

Limitations/Caveats

Investigators were only able to enroll 5 patients in 2 years, therefore, study was terminated early.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.