Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers

Efficacy of Low Dose of Proton Pumb Inhabitor in Treatment Upper Gastrointestinal Bleeding

Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Hemorrhage; Marginal Ulcer; Gastroduodenal Ulcer
• Intervention / Treatment: Drug: Omeprazole 40 MG

Detailed Description

Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding

• Study Type: Observational
• Enrollment (Actual): 295

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, +963
    • Damascus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the gastrointestinal department of damascus hospital

Description

Criteria:

Inclusion Criteria:

High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata, active bleeding was defined as a continuous blood spurting (Forrest IA) oozing (Forrest IB) from the ulcer base. A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).

An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion Criteria:

ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low Dose PPI; patients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily	Drug: Omeprazole 40 MG; Omperazole 40 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morality	Determination of mortality rate from ulcer bleeding	within 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebleeding	Determination of the percentage of the return of bleeding represented by recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment	within 1 week
need for surgery	Determine the Surgery rate for treatment Bleeding ulcers within a week	within 1 week
Length of hospital stay	Determining the length of stay in the hospital	within 1 month
Blood transfusions	number of transfusion blood unites during admission	within 1 week

Collaborators and Investigators

• Sponsor: Damascus Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 20, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage; Peptic Ulcer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: G6-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No