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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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