Stress UlcerNCT06586333
Optimizing Stress Ulcer Prophylaxis Practices and Reducing Associated Costs in Intensive Care Units: a Nonrandomized Controlled Study
A study testing stress ulcer prophylaxis in people with Stress Ulcer, run by Altinbas University at 1 site in Turkey (Türkiye).
Trial summary
The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Ulcer
- What is being tested?
- stress ulcer prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Dec 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU.
Who cannot join
- Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/total gastrectomy, or receiving a proton pump inhibitor for therapeutic purposes were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,
Istanbul, Turkey, 34147
About this study
Official title: Evaluation of the Effect of an Education Program on Reducing the Efficacy and Costs of Inappropriate Stress Ulcer Prophylaxis in Intensive Care Units
The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023.
Read the detailed description
The study involved GICU patients as the standard care services observation group (OG). The use of SUP in the GICU was only monitored and noted. In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines [1]. The study duration was six months concurrently in the EICU and the GICU. Before inclusion, written informed consent was obtained from each patient or their parent(s)/legal guardian(s). Subjects with incomplete data were excluded. The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU. Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/total gastrectomy, or receiving a proton pump inhibitor for therapeutic purposes were excluded from the study.
- Conditions
- Stress Ulcer
- Being tested
- stress ulcer prophylaxis
- Keywords
- guidelines, adherence, stress ulcer, intensive care
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ulcer prophylaxisDrug
Also called clinical pharmacist
In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Involved GICU patients as the standard care services observation group (OG). Stress ulcer prophylaxis were only observed and no intervention done |
| Intervention | Experimental | In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP stress ulcer prophylaxis guidelines Receives: Drug: stress ulcer prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates to ASHP guidelines
% of physician who adhere to ASHP guidelines
Measured: 6 months
Secondary outcomes (1)
Cost saving
The cost saving by adhere to ASHP guidelines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress UlcerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study Design and Participants The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023. The study involved GICU patients as the standard care services observation group (OG). The use of SUP in the GICU was only monitored and noted. In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines \[1\]. The study duration was six months concurrently in the EICU and the GICU. Before inclusion, written informed consent was obtained from each patient or their parent(s)/legal guardian(s). Subjects with incomplete data were excluded. The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU. Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/tot
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Aksoy, Altinbas University
- Investigators
- yunus emre Ayhan, Specialist clinical pharmacy, Study chair, Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586333
- Sponsor's protocol ID
- 2023/181
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of an Education Program on Reducing the Efficacy and Costs of Inappropriate Stress Ulcer Prophylaxis in Intensive Care Units
- ClinicalTrials.gov ID
- NCT06586333
- Acronym / sponsor ID
- 2023/181
- Conditions
- Stress Ulcer
- Keywords
- guidelines, adherence, stress ulcer, intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 19 Sep 2024 (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.
The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023.
Detailed description
The study involved GICU patients as the standard care services observation group (OG). The use of SUP in the GICU was only monitored and noted. In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines [1]. The study duration was six months concurrently in the EICU and the GICU. Before inclusion, written informed consent was obtained from each patient or their parent(s)/legal guardian(s). Subjects with incomplete data were excluded. The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU. Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/total gastrectomy, or receiving a proton pump inhibitor for therapeutic purposes were excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Design and Participants The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023. The study involved GICU patients as the standard care services observation group (OG). The use of SUP in the GICU was only monitored and noted. In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines [1]. The study duration was six months concurrently in the EICU and the GICU. Before inclusion, written informed consent was obtained from each patient or their parent(s)/legal guardian(s). Subjects with incomplete data were excluded. The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU. Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/tot
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Involved GICU patients as the standard care services observation group (OG). Stress ulcer prophylaxis were only observed and no intervention done |
| Intervention | Experimental | Drug: stress ulcer prophylaxisIn the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP stress ulcer prophylaxis guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU.
Key exclusion criteria (1 listed)
- Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/total gastrectomy, or receiving a proton pump inhibitor for therapeutic purposes were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress ulcer prophylaxisAlso: clinical pharmacistIn the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines | Drug | Intervention |
Primary outcome
Adherence rates to ASHP guidelines
Time frame: 6 months
% of physician who adhere to ASHP guidelines
1 secondary outcome
Cost saving
Time frame: 6 months
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
yunus emre Ayhan, Specialist clinical pharmacy study chair
Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ulcer prophylaxis in people with Stress Ulcer, run by Altinbas University 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 1 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 19 Sep 2024. 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?
Adherence rates to ASHP guidelines (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.