Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03814421
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2019-01-07
Brief Title:
Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Sponsor:
Samsung Changwon Hospital
Organization:
Samsung Changwon Hospital
Study Overview
Official Title:
Effect of Intermittent Versus Continuous Intravenous Pantoprazole for Prevention of Bleeding After Endoscopic Therapy of Bleeding Peptic Ulcers
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
We prepare this study to compare the efficacy of intermittent intravenous PPI infusion relatively low dose PPI therapy than continous PPI infusion method Our hypothesis is that intermittent 40mg as a bolus injection daily for 72 hours PPI therapy is not inferior to conventional high dose therapy
Detailed Description:
Background Current guidelines recommend an intravenous bolus dose of a proton pump inhibitorPPI followed by continuous PPI infusion after endoscopic therapy in patients with high-risk peptic ulcer bleeding However intermittent PPI have not been inferior to continuous PPI infusion regimens in recent studies
Objective The aim of this study was to compare the effect of intermittent 40mg as a bolus injection daily for 72hours versus continuous 40mg as a bolus injection followed by continuous infusion at 8mghr for 72hours intravenous pantoprazole for prevention of bleeding after endoscopic therapy of peptic ulcer bleeding Also the same comparison was performed in high-risk patients Rockall scores 6
Methods This single center cross-sectional study was conducted from january 2010 through december 2013 Patients who presented with overt or suspected upper gastrointestinal bleeding based on hematemesis andor melena were eligible These eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization Exclusion criteria were refusal of endoscopy gastrointestinal malignancy Mallory-Weiss syndrome variceal bleeding bleeding dt endoscopic procedure small bowel bleeding serious medical disease etc Demographic and medical data were obtained from the patients medical records Current or past history of medical diagnosis and drug history were also recorded Statistical analysis performed using SPSS 210 software
Objective The aim of this study was to compare the effect of intermittent 40mg as a bolus injection daily for 72hours versus continuous 40mg as a bolus injection followed by continuous infusion at 8mghr for 72hours intravenous pantoprazole for prevention of bleeding after endoscopic therapy of peptic ulcer bleeding Also the same comparison was performed in high-risk patients Rockall scores 6
Methods This single center cross-sectional study was conducted from january 2010 through december 2013 Patients who presented with overt or suspected upper gastrointestinal bleeding based on hematemesis andor melena were eligible These eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization Exclusion criteria were refusal of endoscopy gastrointestinal malignancy Mallory-Weiss syndrome variceal bleeding bleeding dt endoscopic procedure small bowel bleeding serious medical disease etc Demographic and medical data were obtained from the patients medical records Current or past history of medical diagnosis and drug history were also recorded Statistical analysis performed using SPSS 210 software
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