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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06062719
Study type Interventional
Source National Hepatology & Tropical Medicine Research Institute
Contact Eman Ibrahim El-Desoki Mahmoud
Phone +201227409501
Email eman18350@gmail.com
Status Recruiting
Phase Phase 2/Phase 3
Start date August 23, 2023
Completion date January 2025