Search / Trial NCT06225167

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

Launched by METHODIST HEALTH SYSTEM · Jan 16, 2024

Trial Information

Current as of October 03, 2024

Completed

Keywords

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...

Gender

ALL

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Richardson, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0