OctreotidePhase 2NCT02916433
Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients
A Phase 2 study testing Octreotide in people with Octreotide and Sputum, run by Danbury Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Octreotide, Sputum
- What is being tested?
- Octreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Octreotide, Sputum
- Being tested
- Octreotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Also called Sandostatin, Sandostatin LAR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 24, 48, 72 hours
Secondary outcomes (1)
Extubation Within 72 Hours
Percentage of patients who were extubated within 72 hours of intervention initiation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OctreotideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joann Petrini, PhD, MPH, Danbury Hospital
- Investigators
- Abhijith Hegde, MD, Principal investigator, Danbury Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916433
- Sponsor's protocol ID
- 16-1101
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2016
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02916433
- Acronym / sponsor ID
- 16-1101
- Conditions
- Octreotide, Sputum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Danbury HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –This group will continue to receive treatments that have already been initiated to manage bronchial secretions. |
| Octreotide | Experimental | Drug: OctreotideThis group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctreotideAlso: Sandostatin, Sandostatin LAR | Drug | Octreotide |
Primary outcome
Bronchial Secretion Volume Over Preceding 24 Hour Period
Time frame: 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
1 secondary outcome
Extubation Within 72 Hours
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhijith Hegde, MD principal investigator
Danbury Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octreotide in people with Octreotide and Sputum, run by Danbury Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial Secretion Volume Over Preceding 24 Hour Period (time frame: baseline, 24, 48, 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.