Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062719
Status:
RECRUITING
Last Update Posted:
2023-10-02
First Post:
2023-08-29
Brief Title:
Role of Octreotide in Non Variceal Bleeding
Sponsor:
National Hepatology Tropical Medicine Research Institute
Organization:
National Hepatology Tropical Medicine Research Institute
Study Overview
Official Title:
Role of Octreotide Intravenous Infusion in Non-variceal GI Bleeding in ICU
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 mgh 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 μgh 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
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 mgh 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 μgh 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None