Trial Outcomes & Findings for Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients (NCT NCT02916433)

NCT ID: NCT02916433

Last Updated: 2020-10-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: baseline, 24, 48, 72 hours
• Results posted on: 2020-10-08

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Usual Care This group will continue to receive treatments that have already been initiated to manage bronchial secretions.	Octreotide This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide. Octreotide
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Usual Care n=1 Participants This group will continue to receive treatments that have already been initiated to manage bronchial secretions.	Octreotide n=2 Participants This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.	Total n=3 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION NA • n=1 Participants	59.5 years STANDARD_DEVIATION 2.1 • n=2 Participants	61 years STANDARD_DEVIATION 3 • n=3 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	0 Participants n=2 Participants	1 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	2 Participants n=2 Participants	2 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Usual Care n=1 Participants 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.	Octreotide #1 n=1 Participants 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.	Octreotide #2 n=1 Participants 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.
Bronchial Secretion Volume Over Preceding 24 Hour Period Baseline	220 mL/24 hr	310 mL/24 hr	200 mL/24 hr
Bronchial Secretion Volume Over Preceding 24 Hour Period 24 hr time point	70 mL/24 hr	185 mL/24 hr	185 mL/24 hr
Bronchial Secretion Volume Over Preceding 24 Hour Period 48 hr time point	195 mL/24 hr	120 mL/24 hr	170 mL/24 hr
Bronchial Secretion Volume Over Preceding 24 Hour Period 72 hr time point	25 mL/24 hr	NA mL/24 hr Patient discharged before this time point	140 mL/24 hr

SECONDARY outcome

Timeframe: 72 hours

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

Outcome measures

Measure	Usual Care n=1 Participants 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.	Octreotide #1 n=2 Participants 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.	Octreotide #2 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.
Extubation Within 72 Hours	0 percentage of patients	50 percentage of patients	—

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Octreotide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joann Petrini

Western Connecticut Health Network

Phone: 203-739-6882

Email: Joann.Petrini@wchn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place