Role of Octreotide in Non Variceal Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Octreotide Intravenous Infusion in Non-variceal GI Bleeding in ICU

Conditions
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Non-variceal Gastrointestinal Bleeding

Intervention / Treatment
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* Drug: PPI group
* Drug: PPI plus octreotide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>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<br>* 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<br>|
| Experimental: study<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of rebeeding | efficacy of octreotide infusion on the incidence of rebleeding7 days post randomization. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood transfusion | units of transfusions | during 72 hours | 
| length of stay | ICU stay | during the study UP TO 24 weeks | 
| length of stay | hospital stay | during the study up to 24 weeks | 
| mechanical ventilation | incidence of need for mechanical ventilation | 72 hours | 
| mortality | non bleeding cause of mortality | during the study up to 24 weeks |