Upper Gastrointestinal Bleeding, Proton Pump InhibitorsNCT05467358
The Effect of Using Preendoscopic Proton Pump Inhibitors in Upper Gastrointestinal System Bleeding on Patient Prognosis
An observational study of Upper Gastrointestinal Bleeding, Proton Pump Inhibitors, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding, Proton Pump Inhibitors
- Type of treatment
- Injection or infusion
- How many people
- 1,100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients admitted to the emergency department with suspected upper gastrointestinal bleeding and undergoing endoscopy
Who may be able to join
- having an endoscopy at the time of admission to the emergency room
- Glasgow Blatchford score of 2 or higher
- be over 18 years old
Who cannot join
- patients who do not meet the inclusion criteria will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Need for repeat endoscopy
Bleeding associated need for reoperation
Measured: 7 days
mortality
illness related death
Measured: 28 days
hospital stay time
hospitalization day
Measured: through study completion, an average of 1 year
cost of transactions
health expenditure during hospital stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jul 2021
- Primary completion1 Mar 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Bleeding, Proton Pump InhibitorsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GÜLHAN KURTOĞLU ÇELİK, Prof.Dr., Study director, ANKARA CİTY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467358
- Sponsor's protocol ID
- AnkaraCHBilkent-nısık-002
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared if researchers who are considering making a meta-analysis on the subject contact.
Publications
Daneshmend TK, Hawkey CJ, Langman MJ, Logan RF, Long RG, Walt RP. Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial. BMJ. 1992 Jan 18;304(6820):143-7. doi: 10.1136/bmj.304.6820.143.
PubMed 1737157Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.
PubMed 17442905Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.
PubMed 33929377Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10.
PubMed 33567467Pouw RE, Barret M, Biermann K, Bisschops R, Czako L, Gecse KB, de Hertogh G, Hucl T, Iacucci M, Jansen M, Rutter M, Savarino E, Spaander MCW, Schmidt PT, Vieth M, Dinis-Ribeiro M, van Hooft JE. Endoscopic tissue sampling - Part 1: Upper gastrointestinal and hepatopancreatobiliary tracts. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Nov;53(11):1174-1188. doi: 10.1055/a-1611-5091. Epub 2021 Sep 17.
PubMed 34535035
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Preendoscopic Proton Pump Inhibitors in Upper Gastrointestinal System Bleeding on Patient Prognosis
- ClinicalTrials.gov ID
- NCT05467358
- Acronym / sponsor ID
- AnkaraCHBilkent-nısık-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the emergency department with suspected upper gastrointestinal bleeding and undergoing endoscopy
Key inclusion criteria (3 listed)
- having an endoscopy at the time of admission to the emergency room
- Glasgow Blatchford score of 2 or higher
- be over 18 years old
Key exclusion criteria (1 listed)
- patients who do not meet the inclusion criteria will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Need for repeat endoscopy
Time frame: 7 days
Bleeding associated need for reoperation
mortality
Time frame: 28 days
illness related death
hospital stay time
Time frame: through study completion, an average of 1 year
hospitalization day
cost of transactions
Time frame: through study completion, an average of 1 year
health expenditure during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 1737157Daneshmend TK, Hawkey CJ, Langman MJ, Logan RF, Long RG, Walt RP. Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial. BMJ. 1992 Jan 18;304(6820):143-7. doi: 10.1136/bmj.304.6820.143.
- Background: PubMed 17442905Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.
- Background: PubMed 33929377Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.
- Background: PubMed 33567467Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10.
- Background: PubMed 34535035Pouw RE, Barret M, Biermann K, Bisschops R, Czako L, Gecse KB, de Hertogh G, Hucl T, Iacucci M, Jansen M, Rutter M, Savarino E, Spaander MCW, Schmidt PT, Vieth M, Dinis-Ribeiro M, van Hooft JE. Endoscopic tissue sampling - Part 1: Upper gastrointestinal and hepatopancreatobiliary tracts. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Nov;53(11):1174-1188. doi: 10.1055/a-1611-5091. Epub 2021 Sep 17.
- Individual participant dataSharing planned: Undecided. Data can be shared if researchers who are considering making a meta-analysis on the subject contact.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÜLHAN KURTOĞLU ÇELİK, Prof.Dr. study director
ANKARA CİTY HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Bleeding, Proton Pump Inhibitors, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for repeat endoscopy (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05467358, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.