Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit
NCT ID: NCT06225167
Last Updated: 2024-03-28
Study Results
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Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2023-05-13
2023-07-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Protocol Group
Patients will be analyzed during the time frame of February 2020 to February 2023 for the protocol group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Heidi Michaels, PharmD
Role: PRINCIPAL_INVESTIGATOR
Methodist Health System
Locations
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Methodist Richardson Medical Center
Richardson, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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005.PHA.2023.R
Identifier Type: -
Identifier Source: org_study_id
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