Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

NCTNCT02916433 (opens ClinicalTrials.gov in a new tab)Other id16-1101
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
5 participants (actual)
Sponsor
Danbury Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2016
Primary completion
Feb 2018
Completion
Feb 2019
First posted
27 Sept 2016 (estimated)
Last update posted
8 Oct 2020
Conditions
Octreotide · Sputum

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 2

    Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

    NCT02916433

    Sept 2016 to Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OctreotideDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bronchial Secretion Volume Over Preceding 24 Hour Period

    Time frame · baseline, 24, 48, 72 hours

    Registry description

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

Secondary outcomes(1)

  1. Extubation Within 72 Hours

    Time frame · 72 hours

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· baseline, 24, 48, 72 hours

Bronchial Secretion Volume Over Preceding 24 Hour Period

GroupValue (mL/24 hr)
Usual Care220
Octreotide #1310
Octreotide #2200
Secondary and other outcome results(1)
Secondary outcomeNumber· 72 hours

Extubation Within 72 Hours

GroupValue (percentage of patients)
Usual Care0
Octreotide50

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Usual CareThis group will continue to receive treatments that have already been initiated to manage bronchial secretions.0 / 10 / 10 / 1
OctreotideThis group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.0 / 20 / 20 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.