Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit

NCT06225167 | Completed DMC

• 1 other identifier: 005.PHA.2023.R
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacologic stress ulcer prophylaxis is routinely used in the intensive care unit (ICU) to prevent upper gastrointestinal (GI) bleeding in critically ill patients.

Conditions

Stress Ulcer

Outcome Measures

Primary Outcomes (1)

• compare the incidence of overt GI bleeds

  To compare the incidence of overt GI bleeds (defined as hematemesis, bloody nasogastric tube aspirate, or melena) between patients who were on stress ulcer prophylaxis versus patients whose acid suppression therapy was discontinued through the stress ulcer prophylaxis minimization protocol.

  24 hours

Secondary Outcomes (9)

• Identify the acid suppressive therapy reorder rate

  24 hours

• Number of doses avoided

  24 hours

• Incidences of hospital acquired pneumonia (HAP)

  24 hours

• Incidences of C.Difficile infection

  24 hours

• ICU length of stay

  24 hours

Study Arms (2)

Protocol Group

Patients will be analyzed during the time frame of February 2020 to February 2023 for the protocol group

Behavioral: To evaluate the effectiveness and safety of a pharmacist-driven protocol to discontinue stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria.

Non Protocol Group

Patients will be analyzed during the time frame of February 2017 to February 2020 for the non-protocol group.

Behavioral: To evaluate the effectiveness and safety of a pharmacist-driven protocol to discontinue stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria.

Interventions

To evaluate the effectiveness and safety of a pharmacist-driven protocol to discontinue stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria. BEHAVIORAL

To evaluate the effectiveness and safety of a pharmacist-driven protocol to discontinue stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria. To compare the incidence of overt GI bleeds (defined as hematemesis, bloody nasogastric tube aspirate, or melena) between patients who were on stress ulcer prophylaxis versus patients whose acid suppression therapy was discontinued through the stress ulcer prophylaxis minimization protocol.

Non Protocol Group; Protocol Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients ≥18 years ICU location status stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria.

You may qualify if:

• Patients ≥18 years ICU location status

You may not qualify if:

• If patient has one of the following:
• Coagulopathy (defined as: platelets \< 50,000/µL, international normalized ratio(INR) \> 1.5, or partial thromboplastin time \> 2 times the control value)
• Mechanical ventilation for \> 48 hours and on \< 50% goal tube feeds
• Shock state on vasopressors/inotropes and on \< 50% goal tube feeds (or \< 50% of diet)
• On total parenteral nutrition
• Use of acid suppressive therapy prior to admission
• Admission with GI bleeding
• History of peptic ulcer disease
• Surgery on the GI tract or cardiac surgery during the current hospital admission
• Pregnancy
• H. pylori infection treatment
• Hypersecretory disorder (ex: Zollinger-Ellison)
• Known erosive esophagitis/gastritis (not heartburn or gastroesophageal reflux disease)
• Traumatic brain injury with Glasgow Coma Scale score ≤ 10
• Major burn (˃30% body surface area)

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

Location

Related Publications (10)

• Cook D, Guyatt G. Prophylaxis against Upper Gastrointestinal Bleeding in Hospitalized Patients. N Engl J Med. 2018 Jun 28;378(26):2506-2516. doi: 10.1056/NEJMra1605507. No abstract available.

  PMID: 29949497 BACKGROUND

• Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. doi: 10.1056/NEJM199402103300601.

  PMID: 8284001 BACKGROUND

• ASHP Therapeutic Guidelines on Stress Ulcer Prophylaxis. ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998. Am J Health Syst Pharm. 1999 Feb 15;56(4):347-79. doi: 10.1093/ajhp/56.4.347. No abstract available.

  PMID: 10690219 BACKGROUND

• 4. Guillamondegui OD, et al. Practice management guidelines for stress ulcer prophylaxis. Eastern Association for the Surgery of Trauma (EAST); 2008.

  BACKGROUND

• Saeed M, Bass S, Chaisson NF. Which ICU patients need stress ulcer prophylaxis? Cleve Clin J Med. 2022 Jul 1;89(7):363-367. doi: 10.3949/ccjm.89a.21085.

  PMID: 35777844 BACKGROUND

• Kantorova I, Svoboda P, Scheer P, Doubek J, Rehorkova D, Bosakova H, Ochmann J. Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. Hepatogastroenterology. 2004 May-Jun;51(57):757-61.

  PMID: 15143910 BACKGROUND

• Marik PE, Vasu T, Hirani A, Pachinburavan M. Stress ulcer prophylaxis in the new millennium: a systematic review and meta-analysis. Crit Care Med. 2010 Nov;38(11):2222-8. doi: 10.1097/CCM.0b013e3181f17adf.

  PMID: 20711074 BACKGROUND

• Selvanderan SP, Summers MJ, Finnis ME, Plummer MP, Ali Abdelhamid Y, Anderson MB, Chapman MJ, Rayner CK, Deane AM. Pantoprazole or Placebo for Stress Ulcer Prophylaxis (POP-UP): Randomized Double-Blind Exploratory Study. Crit Care Med. 2016 Oct;44(10):1842-50. doi: 10.1097/CCM.0000000000001819.

  PMID: 27635481 BACKGROUND

• Ogasawara O, Kojima T, Miyazu M, Sobue K. Impact of the stress ulcer prophylactic protocol on reducing the unnecessary administration of stress ulcer medications and gastrointestinal bleeding: a single-center, retrospective pre-post study. J Intensive Care. 2020 Jan 16;8:10. doi: 10.1186/s40560-020-0427-8. eCollection 2020.

  PMID: 31988751 BACKGROUND

• 11. Dhand, ND, Khatkar MS (2014). Statulator: An online statistical calculator. Sample Size Calculator for Comparing Two Independent Proportions. Accessed 16 March 2023 at http://statulator.com/SampleSize/ss2P.html.

  BACKGROUND

MeSH Terms

Conditions

Duodenal Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Heidi Michaels, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: January 25, 2024
• Study Start: May 13, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: March 23, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: Clinical Research Institute

Locations

US (1)