Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Effect of Intermittent Versus Continuous Intravenous Pantoprazole for Prevention of Bleeding After Endoscopic Therapy of Bleeding Peptic Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(PPI) 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 8mg/hr 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 and/or 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 d/t 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 21.0 software.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gyeongsangnam-do
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Changwon, Gyeongsangnam-do, Korea, Republic of, 51353
- Samsung Changwon Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 18 years or older who had undergone gastroscopy for melena, hematochezia or hematemesis due to bleeding peptic ulcers 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:
- refusal of endoscopy, gastrointestinal malignancy, Mallory-Weiss syndrome, variceal bleeding, bleeding d/t endoscopic procedure, small bowel bleeding, serious medical disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Low dose intermittent
Pantoprazole 40mg as a bolus injection daily for 72hours
|
Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(PPI) followed by continuous PPI infusion after endoscopic therapy in patients with high-risk bleeding peptic ulcers.
However, recent many studies suggests intermittent low dose PPI infusion might have equal efficacy at preventing peptic ulcer hemorrhage recurrence.
So, the present investigator assumed that intermittent administration of proton pump inhibitor will not be different from administration of continuous proton pump inhibitor for the prevention of rebleeding in patients with peptic ulcer bleeding.
Also, intermittent proton pump inhibitor administration in patients with high risk of rebleeding (Rockall score 6 points or more) will not be different from prevention of rebleeding compared with continuous proton pump inhibitor administration.
|
|
ACTIVE_COMPARATOR: High dose continous
Pantoprazole 40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours
|
Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(PPI) followed by continuous PPI infusion after endoscopic therapy in patients with high-risk bleeding peptic ulcers.
However, recent many studies suggests intermittent low dose PPI infusion might have equal efficacy at preventing peptic ulcer hemorrhage recurrence.
So, the present investigator assumed that intermittent administration of proton pump inhibitor will not be different from administration of continuous proton pump inhibitor for the prevention of rebleeding in patients with peptic ulcer bleeding.
Also, intermittent proton pump inhibitor administration in patients with high risk of rebleeding (Rockall score 6 points or more) will not be different from prevention of rebleeding compared with continuous proton pump inhibitor administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rebleeding rates within 7 days
Time Frame: Within 7 days from enrollment of patient
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Rebleeding was defined that endoscopy confirms that the bleeding is completely controlled and the following outcomes occur after initial vital signs are stabilized.
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Within 7 days from enrollment of patient
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Transfusion requirement
Time Frame: within 7 days from enrollment of patient
|
The amount of transfusion that occurred during the period when the patient was in hospital was recorded as unit.
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within 7 days from enrollment of patient
|
|
Hospital stay
Time Frame: within 1 years from enrollment of patient
|
length of hospital stay - From the day the patient visits the emergency room to the day when the patient gets discharged
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within 1 years from enrollment of patient
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Death related with Upper GI bleeding
Time Frame: within 1 years from enrollment of patient
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All-cause or bleeding-related mortality was observed within 1 year of patient enrollment.
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within 1 years from enrollment of patient
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Operation d/t Upper GI bleeding
Time Frame: within 1 years from enrollment of patient
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This result is defined as exploratory laparatomy associated with peptic ulcer bleeding, gastric and duodenal resection anastomosis, and vagotomy.
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within 1 years from enrollment of patient
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sung JJ, Chiu PW, Chan FKL, Lau JY, Goh KL, Ho LH, Jung HY, Sollano JD, Gotoda T, Reddy N, Singh R, Sugano K, Wu KC, Wu CY, Bjorkman DJ, Jensen DM, Kuipers EJ, Lanas A. Asia-Pacific working group consensus on non-variceal upper gastrointestinal bleeding: an update 2018. Gut. 2018 Oct;67(10):1757-1768. doi: 10.1136/gutjnl-2018-316276. Epub 2018 Apr 24. Erratum In: Gut. 2019 Feb;68(2):380.
- Sreedharan A, Martin J, Leontiadis GI, Dorward S, Howden CW, Forman D, Moayyedi P. Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD005415. doi: 10.1002/14651858.CD005415.pub3.
- Cook D, Guyatt G. Prophylaxis against Upper Gastrointestinal Bleeding in Hospitalized Patients. N Engl J Med. 2018 Jun 28;378(26):2506-2516. doi: 10.1056/NEJMra1605507. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-SCMC-008-00
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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