Octreotide for Management of Bronchorrhea in Mechanically Ventilated Patients

What Was Tested

This registered phase 2 trial tested Octreotide.

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.

It had two arms (groups): Usual care (no intervention) and Octreotide (experimental).

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

This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients are being weaned from mechanical ventilation.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: known hypersensitivity to octreotide; persistent bradycardia (hr \< 60); mobitz type ii or 3rd degree heart block in patients without a pacemaker.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2016-09 with completion listed for 2018-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bronchial Secretion Volume Over Preceding 24 Hour Period (time frame: baseline, 24, 48, 72 hours).

It also tracked 1 secondary outcome, for example Extubation Within 72 Hours.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.