The Effect of Using Preendoscopic Proton Pump Inhibitors in Upper Gastrointestinal System Bleeding on Patient Prognosis

September 26, 2023 updated by: Ankara City Hospital Bilkent
In this study, we aimed to investigate the effectiveness of ppi use in upper gastrointestinal bleeding in patients over the age of 18 who underwent endoscopy on mortality, length of hospital stay, rebleeding, and cost. The European Society of Gastrointestinal Endoscopy 2021 recommends the use of preendoscopic ppi in patients with nonvariceal upper gastrointestinal bleeding as it reduces the need for endoscopic treatment. This recommendation is recommended by the British Institute for Health and Care Excellence not to use proton pump inhibitors. Likewise, the 2021 American Gastroenterology Association did not make a recommendation for its use because the benefit of using preendoscopic ppi is uncertain. This has led to confusion about the efficacy of ppi and has questioned the necessity of routinely given high-dose ppi therapy. In this study, we aim to reveal the effectiveness of the treatment by comparing the patients who were given and not given ppi. Our research is a retrospective cohort study. Patients over the age of 18 who applied to the emergency department and had a preliminary diagnosis of upper gastrointestinal bleeding and underwent endoscopy will be included in the study. Patients who underwent endoscopy and were given ppi and those who were not will be compared. In upper gastrointestinal bleeding, patients with a Glasgow Blatchford score of 2 and above are taken to endoscopy. Therefore, patients over the age of 18 who underwent endoscopy will be included in the study.

Study Overview

Status

Completed

Conditions

Detailed Description

Due to the problems experienced in the supply of ppi, ppi was not available in our hospital for a while. Therefore, ppi could not be given to the patients. It was started to be given after the drug was re-supplied. In our study, we retrospectively analyzed patients who could and could not receive ppi. The data of the patients were as follows: age, gender, complaints on admission, known diseases, vital signs, medications used, rectal examination, whole blood parameters, biochemistry parameters, Glasgow Blatchford scores, endoscopy results, whether they received blood products, how much of each product they received, emergency We recorded service outcomes and emergency room costs.

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent Sehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients admitted to the emergency department with suspected upper gastrointestinal bleeding and undergoing endoscopy

Description

Inclusion Criteria:

  • having an endoscopy at the time of admission to the emergency room
  • Glasgow Blatchford score of 2 or higher
  • be over 18 years old

Exclusion Criteria:

  • patients who do not meet the inclusion criteria will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with preendoscopic ppi order
Patients receiving 80 mg esomeprazole loading and 8 mg esomeprazole infusion per hour before endoscopic treatment
Patients with preendoscopic cannot be ppi order
patients who could not get ppi before endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for repeat endoscopy
Time Frame: 7 days
Bleeding associated need for reoperation
7 days
mortality
Time Frame: 28 days
illness related death
28 days
hospital stay time
Time Frame: through study completion, an average of 1 year
hospitalization day
through study completion, an average of 1 year
cost of transactions
Time Frame: through study completion, an average of 1 year
health expenditure during hospital stay
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Director: GÜLHAN KURTOĞLU ÇELİK, Prof.Dr., Ankara City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-nısık-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data can be shared if researchers who are considering making a meta-analysis on the subject contact.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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