Octreotide, Sputum
Conditions
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.
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.
Interventions
DRUGOctreotide
Sponsors
Danbury Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Extubation Within 72 Hours | 72 hours | Percentage of patients who were extubated within 72 hours of intervention initiation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care This group will continue to receive treatments that have already been initiated to manage bronchial secretions. | 1 |
| Octreotide This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide. | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Octreotide | Total |
|---|---|---|---|
| Age, Continuous | 64 years | 59.5 years STANDARD_DEVIATION 2.1 | 61 years STANDARD_DEVIATION 3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
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
Time frame: baseline, 24, 48, 72 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Bronchial Secretion Volume Over Preceding 24 Hour Period | 24 hr time point | 70 mL/24 hr |
| Usual Care | Bronchial Secretion Volume Over Preceding 24 Hour Period | Baseline | 220 mL/24 hr |
| Usual Care | Bronchial Secretion Volume Over Preceding 24 Hour Period | 48 hr time point | 195 mL/24 hr |
| Usual Care | Bronchial Secretion Volume Over Preceding 24 Hour Period | 72 hr time point | 25 mL/24 hr |
| Octreotide #1 | Bronchial Secretion Volume Over Preceding 24 Hour Period | 72 hr time point | NA mL/24 hr |
| Octreotide #1 | Bronchial Secretion Volume Over Preceding 24 Hour Period | 48 hr time point | 120 mL/24 hr |
| Octreotide #1 | Bronchial Secretion Volume Over Preceding 24 Hour Period | Baseline | 310 mL/24 hr |
| Octreotide #1 | Bronchial Secretion Volume Over Preceding 24 Hour Period | 24 hr time point | 185 mL/24 hr |
| Octreotide #2 | Bronchial Secretion Volume Over Preceding 24 Hour Period | Baseline | 200 mL/24 hr |
| Octreotide #2 | Bronchial Secretion Volume Over Preceding 24 Hour Period | 24 hr time point | 185 mL/24 hr |
| Octreotide #2 | Bronchial Secretion Volume Over Preceding 24 Hour Period | 48 hr time point | 170 mL/24 hr |
| Octreotide #2 | Bronchial Secretion Volume Over Preceding 24 Hour Period | 72 hr time point | 140 mL/24 hr |
Secondary
Extubation Within 72 Hours
Percentage of patients who were extubated within 72 hours of intervention initiation
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Extubation Within 72 Hours | 0 percentage of patients |
| Octreotide #1 | Extubation Within 72 Hours | 50 percentage of patients |