Role of Octreotide in Non Variceal Bleeding

Role of Octreotide Intravenous Infusion in Non-variceal GI Bleeding in ICU

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.

Study Overview

• Status: Recruiting
• Conditions: Non-variceal Gastrointestinal Bleeding
• Intervention / Treatment: Drug: PPI group; Drug: PPI plus octreotide

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Eman Ibrahim El-Desoki Mahmoud; Phone Number: +201227409501; Email: eman18350@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 4260010
    • Recruiting
    • NHTMRI
    • Contact: Eman Ibrahim El-Desoki Mahmoud, MD; Phone Number: +201227409501; Email: eman18350@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; 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; 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
Experimental: study; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of rebeeding	efficacy of octreotide infusion on the incidence of rebleeding7 days post randomization.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood transfusion	units of transfusions	during 72 hours
length of stay	ICU stay	during the study UP TO 24 weeks
length of stay	hospital stay	during the study up to 24 weeks
mechanical ventilation	incidence of need for mechanical ventilation	72 hours
mortality	non bleeding cause of mortality	during the study up to 24 weeks

Collaborators and Investigators

• Sponsor: National Hepatology & Tropical Medicine Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: 26-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No