Clinical trial NCT06062719: Role of Octreotide in Non Variceal Bleeding
Official title: Role of Octreotide Intravenous Infusion in Non-variceal GI Bleeding in ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Non-variceal Gastrointestinal Bleeding
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2023-10-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: incidence of rebeeding
timeFrame: 7 days
Secondary outcomes:
measure: blood transfusion
timeFrame: during 72 hours
measure: length of stay
timeFrame: during the study UP TO 24 weeks
measure: length of stay
timeFrame: during the study up to 24 weeks
measure: mechanical ventilation
timeFrame: 72 hours
measure: mortality
timeFrame: during the study up to 24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
References: