Role of Octreotide in Non Variceal Bleeding

What Was Tested

This registered phase 2, phase 3 trial tested Octreotide.

It had two arms (groups): control (active comparator) and study (experimental).

The registry classes the interventions as drug.

More on the Plan

All patients admitted will receive the routine monitoring for the vital signs and supportive treatment.

Resuscitation of a hemodynamically unstable patient begins with assessing and addressing the "ABCs" (i.e. airway, breathing, circulation) of initial management.

Intravenous access will be inserted and fluid resuscitation, blood, and blood products transfusion according to laboratory results.

Nasogastric tune will be inserted andperform lavage, and endoscopic consultation post resuscitation within 24 hours.

Who Took Part

56 planned participants were the target.

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: The subjects are adults aged ≥18years old.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: if they have variceal bleeding; received active endoscopic treatment (e.g. hemoclips or monopolar coagulation); known hypersensitivity to somatostatin analogue (octreotide) or any of its components.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-08-23 with completion listed for 2024-09.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: incidence of rebeeding (time frame: 7 days).

It also tracked 5 secondary outcomes, for example blood transfusion, length of stay, length of stay, mechanical ventilation and mortality.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Octreotide in 56 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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