Role of Octreotide in Non Variceal Bleeding

NCT ID: NCT06062719

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2025-01-31

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.

Conditions

Non-variceal Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

PPI group

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

PPI plus octreotide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Hepatology & Tropical Medicine Research Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

ICU

fellow of intensive care medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NHTMRI

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Eman Ibrahim El-Desoki Mahmoud

Role: CONTACT

eman18350@gmail.com

+201227409501

Facility Contacts

Eman Ibrahim El-Desoki Mahmoud, MD

Role: primary

eman18350@gmail.com

+201227409501

Other Identifiers

26-2023

Identifier Type: -

Identifier Source: org_study_id