Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Primary Purpose
Peptic Ulcer Hemorrhage, Peptic Ulcer, Acute With Hemorrhage, Peptic Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intermittent (40mg as a bolus injection daily for 72hours)
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Hemorrhage
Eligibility Criteria
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
Sites / Locations
- Samsung Changwon Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low dose intermittent
High dose continous
Arm Description
Pantoprazole 40mg as a bolus injection daily for 72hours
Pantoprazole 40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours
Outcomes
Primary Outcome Measures
rebleeding rates within 7 days
Rebleeding was defined that endoscopy confirms that the bleeding is completely controlled and the following outcomes occur after initial vital signs are stabilized.
when a new hematemesis, hematochezia, occurs.
melena occurs and blood pressure decreases (less than 90 mmHg) or pulse rate increase (110 beats per minute) or hemoglobin decline (greater than 3 g / dL) within 24 hours.
Secondary Outcome Measures
Transfusion requirement
The amount of transfusion that occurred during the period when the patient was in hospital was recorded as unit.
Hospital stay
length of hospital stay - From the day the patient visits the emergency room to the day when the patient gets discharged
Death related with Upper GI bleeding
All-cause or bleeding-related mortality was observed within 1 year of patient enrollment.
Operation d/t Upper GI bleeding
This result is defined as exploratory laparatomy associated with peptic ulcer bleeding, gastric and duodenal resection anastomosis, and vagotomy.
Full Information
NCT ID
NCT03814421
First Posted
January 7, 2019
Last Updated
October 20, 2020
Sponsor
Samsung Changwon Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03814421
Brief Title
Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Official Title
Effect of Intermittent Versus Continuous Intravenous Pantoprazole for Prevention of Bleeding After Endoscopic Therapy of Bleeding Peptic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Changwon Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage, Peptic Ulcer, Acute With Hemorrhage, Peptic Ulcer, Proton Pump Inhibitor Overdose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose intermittent
Arm Type
Experimental
Arm Description
Pantoprazole 40mg as a bolus injection daily for 72hours
Arm Title
High dose continous
Arm Type
Active Comparator
Arm Description
Pantoprazole 40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours
Intervention Type
Drug
Intervention Name(s)
intermittent (40mg as a bolus injection daily for 72hours)
Intervention Description
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.
Primary Outcome Measure Information:
Title
rebleeding rates within 7 days
Description
Rebleeding was defined that endoscopy confirms that the bleeding is completely controlled and the following outcomes occur after initial vital signs are stabilized.
when a new hematemesis, hematochezia, occurs.
melena occurs and blood pressure decreases (less than 90 mmHg) or pulse rate increase (110 beats per minute) or hemoglobin decline (greater than 3 g / dL) within 24 hours.
Time Frame
Within 7 days from enrollment of patient
Secondary Outcome Measure Information:
Title
Transfusion requirement
Description
The amount of transfusion that occurred during the period when the patient was in hospital was recorded as unit.
Time Frame
within 7 days from enrollment of patient
Title
Hospital stay
Description
length of hospital stay - From the day the patient visits the emergency room to the day when the patient gets discharged
Time Frame
within 1 years from enrollment of patient
Title
Death related with Upper GI bleeding
Description
All-cause or bleeding-related mortality was observed within 1 year of patient enrollment.
Time Frame
within 1 years from enrollment of patient
Title
Operation d/t Upper GI bleeding
Description
This result is defined as exploratory laparatomy associated with peptic ulcer bleeding, gastric and duodenal resection anastomosis, and vagotomy.
Time Frame
within 1 years from enrollment of patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Changwon Hospital
City
Changwon
State/Province
Gyeongsangnam-do
ZIP/Postal Code
51353
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29691276
Citation
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.
Results Reference
background
PubMed Identifier
20614440
Citation
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.
Results Reference
result
PubMed Identifier
29949497
Citation
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.
Results Reference
result
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Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
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