Stress Ulcer Prophylaxis Practices in the Intensive Care Unit

NCT06620263 | Completed

• 1 other identifier: 249/20.11.2023
• Study Type: observational
• Target: 495
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to examine the adherence of proton pump inhibitors (PPIs), commonly recommended for stress ulcer prevention (SUP) in patients in the intensive care unit (ICU), according to an international guideline. The objective of the study was to enhance the adherence of SUP prescriptions to the guideline, therefore preventing potential adverse effects and avoidable financial burden, and, consequently, attaining cost reduction.

Conditions

Stress Ulcer Prophylaxis

Keywords

Stress ulcer prophylaxis; Proton pump inhibitor; Intensive care unit; Clinical pharmacist

Outcome Measures

Primary Outcomes (1)

• Stress ulcer prophylaxis appropriate rate

  The appropriateness rates of SUP uses for the indication was evaluated according to the Sociedade Portuguesa de Cuidados (SPC) SUP guideline. Accordingly, the adherence rate was calculated by dividing the SUP prescriptions in accordance with the guideline during a patient\'s hospitalization by the SUP use during the entire hospitalization.

  through study completion, an average of 1 year

Study Arms (2)

Pre-education period (PreEd)

In PreEd, the SUP use of patients in the ICU was observed observationally for three months.

Other: Pre-education period (PreEd)

Post-education period (PostEd)

The SUP education program in the ICU was implemented for ICU physicians after examining the patient data in the first three months of the study. In the 3-month PostEd after the education program (April 3, 2024 - July 3, 2024), SUP was only used in patients in the ICU, and no intervention was observed. Throughout the study period, the appropriateness of SUP uses for the indication was evaluated according to the Sociedade Portuguesa de Cuidados (SPC) SUP guideline

Other: Post-education period (PostEd)

Interventions

Pre-education period (PreEd) OTHER

No intervention. ). In PreEd, the SUP use of patients in the ICU was observed observationally for three months (January 1, 2024 - April 1, 2024).

Pre-education period (PreEd)

Post-education period (PostEd) OTHER

In the study, the SUP education program in the ICU was implemented for ICU physicians after examining the patient data in the first three months of the study. In the 3-month PostEd after the education program (April 3, 2024 - July 3, 2024), SUP was only used in patients in the ICU, and no intervention was observed.

Post-education period (PostEd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This population includes ICU patients using PPI for SUP.

You may qualify if:

• Patients aged ≥18 years,
• ICU stay longer than 24 hours,
• PPI use for SUP

You may not qualify if:

• Patients with a diagnosis of gastric cancer
• Patients with a history of gastrointestinal issues
• Individuals who have undergone subtotal or total gastrectomy
• Those using proton pump inhibitors (PPIs) for treatment indications such as dual antiplatelet therapy
• Patients admitted to the intensive care unit (ICU) with gastrointestinal bleeding

Sponsors & Collaborators

• Yunus Emre AYHAN: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Turkey, 34444, Turkey (Türkiye)

Location

Related Publications (1)

• Mendes JJ, Silva MJ, Miguel LS, Goncalves MA, Oliveira MJ, Oliveira CDL, Gouveia J. Sociedade Portuguesa de Cuidados Intensivos guidelines for stress ulcer prophylaxis in the intensive care unit. Rev Bras Ter Intensiva. 2019;31(1):5-14. doi: 10.5935/0103-507X.20190002. Epub 2019 Feb 28.

  PMID: 30843949 BACKGROUND

Related Links

• In this study, the guideline is the reference taken as the source for adherence.

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Clinical Pharmacist

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: January 1, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)