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

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

Study Overview

• Status: Completed
• Conditions: Stress Ulcer
• Intervention / Treatment: 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.

Detailed Description

Historically, the two independent risk factors for stress-related GI bleeds were coagulopathy and mechanical ventilation for more than 48 hours; however, several additional risk factors have been identified, such as shock, multiple organ failure, traumatic brain injury, and major burns.

Acid suppressive medications such as proton pump inhibitors or histamine-2 receptor antagonists are prescribed to reduce the rate of bleeding from stress ulceration despite a lack of benefit from placebo-controlled trials. In addition to lack of proven benefit, the incidence of clinically significant stress-related GI bleeding has decreased over time, likely due to improvements in critical care and earlier enteral feeding.

• Study Type: Observational
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75082
      • Methodist Richardson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Patients ≥18 years ICU location status

Exclusion Criteria:

• 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)
  • Major trauma requiring ICU admission
  • Spinal cord injury requiring ICU admission

If patient has two or more of the following:

• Administration of ˃ 100 mg daily of prednisolone (or equivalent)
• Sepsis
• Acute renal failure
• Acute hepatic failure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the acid suppressive therapy reorder rate	To Identify the acid suppressive therapy reorder frequency	24 hours
Number of doses avoided	Number of acid suppressive therapy doses avoided	24 hours
Incidences of hospital acquired pneumonia (HAP)	Number of HAP cases occurring	24 hours
Incidences of C.Difficile infection	Number of cases of C.Difficile infections occurring	24 hours
ICU length of stay	The time frame of ICU stay	24 hours
incidence of ICU delirium	number of cases with ICU Delirium	24 hours
type of pharmacologic agent used	Different types of medications used	24 hours
number of patients with clinically important GI bleeding	Bleeding defined as overt GI bleeding plus one or more of the following within 24 hours such as decrease in systolic pressure, mean arterial pressure or diastolic pressure, orthostatic hypotension or postural tachycardia , drop in hemoglobin, received transfusions of packed red blood cells or need for vasopressors or invasive interventions like endoscopy.	24 hours
number of discharge prescriptions for acid suppressive therapy	number of patients getting discharged with acid suppressive therapy	24 hours

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Heidi Michaels, PharmD, Methodist Health System

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Peptic Ulcer; Duodenal Ulcer
• Other Study ID Numbers: 005.PHA.2023.R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: Clinical Research Institute
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No