Role of Octreotide in Non Variceal Bleeding

NCT06062719 | Unknown Phase 2

• 1 other identifier: 26-2023
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-variceal Gastrointestinal Bleeding

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 group 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

control

PPI plus octreotide 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

study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

NHTMRI

Cairo, 4260010, Egypt

RECRUITING

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Eman Ibrahim El-Desoki Mahmoud

CONTACT

+201227409501; eman18350@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow of intensive care medicine

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.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 2, 2023
• Study Start: August 23, 2023
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

EG (1)