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CompletedNCT06586333Updated Sep 19, 2024

Optimizing Stress Ulcer Prophylaxis Practices and Reducing Associated Costs in Intensive Care Units: a Nonrandomized Controlled Study

An interventional study of stress ulcer prophylaxis in Stress Ulcer, sponsored by Altinbas University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Altinbas University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stress Ulcer

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Keywords

  • guidelines
  • adherence
  • stress ulcer
  • intensive care
03

In context

Duodenal Ulcer

77 studies on the registry are indexed under Duodenal Ulcer; 5 are open to participants now.

This study's enrollment of 196 is below the median of 254 across 52 interventional studies indexed under Duodenal Ulcer.

Browse Duodenal Ulcer studies →

Lead sponsor

Altinbas University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (actual)

Study arms

  • No intervention
    Control Group

    Involved GICU patients as the standard care services observation group (OG). Stress ulcer prophylaxis were only observed and no intervention done

  • Experimental
    Intervention

    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

    Drug: stress ulcer prophylaxis

Interventions

  • Drugstress ulcer prophylaxis

    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

    Also known as: clinical pharmacist

06

What researchers measure

Primary outcomes

  1. Adherence rates to ASHP guidelines

    % of physician who adhere to ASHP guidelines

    Time frame: 6 months

Secondary outcomes

  1. Cost saving

    The cost saving by adhere to ASHP guidelines

    Time frame: 6 months

07

Study locations

1 site
  • Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,
    Istanbul, Turkey 34147, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Dec 2023, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2024
First posted
Sep 19, 2024
StartActual
Jun 1, 2023
Primary completionActual
Dec 1, 2023
CompletionActual
Dec 1, 2023
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586333
Lead sponsor
Altinbas University
Responsible party
Nilay Aksoy (Assoc.Professor, Altinbas University) — Principal investigator
First posted
Sep 19, 2024
Start date
Jun 1, 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
Sep 19, 2024

Study contacts

yunus emre Ayhan, Specialist clinical pharmacy
study chair · Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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