Clinical trial NCT03814421: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peptic Ulcer Hemorrhage
Peptic Ulcer, Acute With Hemorrhage
Peptic Ulcer
Proton Pump Inhibitor Overdose
Lead sponsor: Samsung Changwon Hospital
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: rebleeding rates within 7 days
timeFrame: Within 7 days from enrollment of patient
Secondary outcomes:
measure: Transfusion requirement
timeFrame: within 7 days from enrollment of patient
measure: Hospital stay
timeFrame: within 1 years from enrollment of patient
measure: Death related with Upper GI bleeding
timeFrame: within 1 years from enrollment of patient
measure: Operation d/t Upper GI bleeding
timeFrame: within 1 years from enrollment of patient
Other outcomes:
Locations:
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital
state: Gyeongsangnam-do
Study officials:
References:
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.
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.
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.