Clinical trial NCT06225167: Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit
Official title: Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Ulcer
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: compare the incidence of overt GI bleeds
timeFrame: 24 hours
Secondary outcomes:
measure: Identify the acid suppressive therapy reorder rate
timeFrame: 24 hours
measure: Number of doses avoided
timeFrame: 24 hours
measure: Incidences of hospital acquired pneumonia (HAP)
timeFrame: 24 hours
measure: Incidences of C.Difficile infection
timeFrame: 24 hours
measure: ICU length of stay
timeFrame: 24 hours
measure: incidence of ICU delirium
timeFrame: 24 hours
measure: type of pharmacologic agent used
timeFrame: 24 hours
measure: number of patients with clinically important GI bleeding
timeFrame: 24 hours
measure: number of discharge prescriptions for acid suppressive therapy
timeFrame: 24 hours
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Heidi Michaels, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 4. Guillamondegui OD, et al. Practice management guidelines for stress ulcer prophylaxis. Eastern Association for the Surgery of Trauma (EAST); 2008.
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.
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.
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.
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.
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.
citation: 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.