Role of Octreotide in Non Variceal Bleeding

Phase 2

Recruiting

• Conditions: Non-variceal Gastrointestinal Bleeding
• Interventions: Drug: PPI group; Drug: PPI plus octreotide

• Registration Number: NCT06062719
• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

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.

Study Timeline

• Study Start: 2023-08-23
• Study First Submitted: 2023-08-29
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-09
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	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
study	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
blood transfusion	during 72 hours	units of transfusions
mechanical ventilation	72 hours	incidence of need for mechanical ventilation
mortality	during the study up to 24 weeks	non bleeding cause of mortality
length of stay	during the study up to 24 weeks	hospital stay

Trial Locations

Locations (1)

NHTMRI; 🇪🇬 Cairo, Egypt