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Outcome Measures

Primary Outcomes (1)

incidence of rebeeding
efficacy of octreotide infusion on the incidence of rebleeding7 days post randomization.
7 days

Secondary Outcomes (5)

blood transfusion
during 72 hours
length of stay
during the study UP TO 24 weeks
length of stay
during the study up to 24 weeks
mechanical ventilation
72 hours
mortality
during the study up to 24 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

80-mg bolus of PPI alone (control group= A), followed by continuous intravenous (IV) infusion at 8 mg/h for a total of 72 hours

Drug: PPI group

study

EXPERIMENTAL

octreotide adjunctive group, in addition to the pantoprazole (Study group= B) for 72 h, received a 100-μg bolus of octreotide, followed by continuous IV infusion of 50 μg/h for a total of 72 hours

Drug: PPI plus octreotide

Interventions

PPI groupDrug

80-mg bolus of PPI alone (control group= A), followed by continuous intravenous (IV) infusion at 8 mg/h for a total of 72 hours

control

PPI plus octreotideDrug

octreotide adjunctive group, in addition to the pantoprazole (Study group= B) for 72 h, received a 100-μg bolus of octreotide, followed by continuous IV infusion of 50 μg/h for a total of 72 hours

study

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The subjects are adults aged ≥18years old
admitted to the intensive care unit of the National hepatology and Tropical Medicine Research institute and Alexandria university presenting with acute non-variceal gastrointestinal bleeding

Study Design

Study Type

interventional

Phase

phase 2 3

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Enrolled patients were assigned to one of two groups. After the initial endoscopy, both groups received either an 80-mg bolus of PPI alone (control group= A), followed by continuous intravenous (IV) infusion at 8 mg/h for a total of 72 hours or the octreotide adjunctive group, in addition to the pantoprazole (Study group= B) for 72 h, received a 100-μg bolus of octreotide, followed by continuous IV infusion of 50 μg/h for a total of 72 hours.

Sponsor Type

OTHER GOV

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

fellow of intensive care medicine

Role of Octreotide in Non Variceal Bleeding

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

control

study

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

control

study

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations