Using octreotide to treat non-variceal gastrointestinal bleeding
Role of Octreotide Intravenous Infusion in Non-variceal GI Bleeding in ICU
PHASE2; PHASE3 · National Hepatology & Tropical Medicine Research Institute · NCT06062719
This study is testing if adding octreotide to standard treatment can help people with non-variceal gastrointestinal bleeding have fewer rebleeding episodes while they're in the intensive care unit.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Hepatology & Tropical Medicine Research Institute (other gov) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06062719 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of octreotide, a somatostatin analogue, in combination with proton pump inhibitors (PPIs) for treating non-variceal gastrointestinal bleeding (NVGIB). Patients admitted to the intensive care unit with acute NVGIB will be randomly assigned to receive either PPIs alone or PPIs plus octreotide. The study aims to provide high-quality evidence on whether octreotide can reduce the risk of rebleeding compared to standard treatment. Participants will be closely monitored for vital signs and laboratory parameters throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older admitted to the intensive care unit with acute non-variceal gastrointestinal bleeding.
Not a fit: Patients with variceal bleeding, active malignancy, or those who have received somatostatin analogues recently will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of rebleeding in patients with non-variceal gastrointestinal bleeding.
How similar studies have performed: Previous studies have suggested potential benefits of somatostatin in this context, but high-quality randomized controlled trials are lacking, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- NHTMRI — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Eman Ibrahim El-Desoki Mahmoud
- Email: eman18350@gmail.com
- Phone: +201227409501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-variceal Gastrointestinal Bleeding