Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

NCT02916433 | Completed Phase 2 Results

• 1 other identifier: 16-1101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Octreotide; Sputum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Extubation Within 72 Hours

  72 hours

Study Arms (2)

Usual care

NO INTERVENTION

This group will continue to receive treatments that have already been initiated to manage bronchial secretions.

Octreotide

EXPERIMENTAL

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

Interventions

Octreotide DRUG

Also known as: Sandostatin, Sandostatin LAR

Octreotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danbury Hospital: lead

Study Sites (1)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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

Results Point of Contact

• Title: Joann Petrini
• Organization: Western Connecticut Health Network

Joann.Petrini@wchn.org

203-739-6882

Study Officials

• Abhijith Hegde, MD

  Danbury Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Outcomes and Health Services Research

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: October 8, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Locations

US (1)