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

Stress Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06225167
• Other study ID #: 005.PHA.2023.R
• Status: Completed
• Start date: May 13, 2023
• Est. completion date: July 17, 2023

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Richardson Medical Center	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (10)

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identify the acid suppressive therapy reorder rate	To Identify the acid suppressive therapy reorder frequency	24 hours
Secondary	Number of doses avoided	Number of acid suppressive therapy doses avoided	24 hours
Secondary	Incidences of hospital acquired pneumonia (HAP)	Number of HAP cases occurring	24 hours
Secondary	Incidences of C.Difficile infection	Number of cases of C.Difficile infections occurring	24 hours
Secondary	ICU length of stay	The time frame of ICU stay	24 hours
Secondary	incidence of ICU delirium	number of cases with ICU Delirium	24 hours
Secondary	type of pharmacologic agent used	Different types of medications used	24 hours
Secondary	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
Secondary	number of discharge prescriptions for acid suppressive therapy	number of patients getting discharged with acid suppressive therapy	24 hours