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Role of Octreotide in Non Variceal Bleeding

Primary Purpose

Non-variceal Gastrointestinal Bleeding

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
PPI group
PPI plus octreotide
Sponsored by
National Hepatology & Tropical Medicine Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-variceal Gastrointestinal Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 pregnancy or breastfeeding active malignancy and use of somatostatin analogue within the past 7 day.

Sites / Locations

  • NHTMRIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

study

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood transfusion
units of transfusions
length of stay
ICU stay
length of stay
hospital stay
mechanical ventilation
incidence of need for mechanical ventilation
mortality
non bleeding cause of mortality

Full Information

First Posted
August 29, 2023
Last Updated
September 28, 2023
Sponsor
National Hepatology & Tropical Medicine Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06062719
Brief Title
Role of Octreotide in Non Variceal Bleeding
Official Title
Role of Octreotide Intravenous Infusion in Non-variceal GI Bleeding in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hepatology & Tropical Medicine Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The rationale for using somatostatin (octreotide0 is that it has been shown to inhibit the secretion of various gastrointestinal hormones, including gastrin and secretin, which can contribute to the development of non-variceal gastrointestinal bleeding (NVGIB). Somatostatin has also been found to reduce splanchnic blood flow, which can decrease the risk of rebleeding in patients with NVGIB. Previous studies have suggested that somatostatin may be effective in reducing the risk of rebleeding in patients with NVGIB, but there is a lack of high-quality randomized controlled trials evaluating its efficacy. Therefore, this study aims to provide more rigorous evidence regarding the use of somatostatin in the management of NVGIB. Aim of the study: To evaluate the efficacy of medical treatment with somatostatin analogue (octreotide) combined with PPI in the treatment of non-variceal gastrointestinal bleeding in comparison to PPI alone a randomized.
Detailed Description
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. Patients who are at an increased risk for aspiration, should be electively intubated. 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. 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. Hourly monitoring for vital signs including pulse, blood pressure, respiratory rate, oxygen saturation by pulse oximetry, 24hours urine output. Daily follow up for complete blood count, coagulation profile, urea, and creatinine will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-variceal Gastrointestinal Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
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
Arm Title
study
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PPI group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PPI plus octreotide
Intervention Description
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
Primary Outcome Measure Information:
Title
incidence of rebeeding
Description
efficacy of octreotide infusion on the incidence of rebleeding7 days post randomization.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
blood transfusion
Description
units of transfusions
Time Frame
during 72 hours
Title
length of stay
Description
ICU stay
Time Frame
during the study UP TO 24 weeks
Title
length of stay
Description
hospital stay
Time Frame
during the study up to 24 weeks
Title
mechanical ventilation
Description
incidence of need for mechanical ventilation
Time Frame
72 hours
Title
mortality
Description
non bleeding cause of mortality
Time Frame
during the study up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 pregnancy or breastfeeding active malignancy and use of somatostatin analogue within the past 7 day.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Ibrahim El-Desoki Mahmoud
Phone
+201227409501
Email
eman18350@gmail.com
Facility Information:
Facility Name
NHTMRI
City
Cairo
ZIP/Postal Code
4260010
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Ibrahim El-Desoki Mahmoud, MD
Phone
+201227409501
Email
eman18350@gmail.com

12. IPD Sharing Statement

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Role of Octreotide in Non Variceal Bleeding

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