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 December 21, 2024

Completed

Keywords

ClinConnect Summary

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

Trial Officials

Heidi Michaels, PharmD

Principal Investigator

Methodist Health System

About Methodist Health System

Methodist Health System is a leading healthcare provider dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care and scientific inquiry, the organization leverages its state-of-the-art facilities and multidisciplinary expertise to conduct rigorous studies across various therapeutic areas. Methodist Health System collaborates with healthcare professionals, researchers, and industry partners to enhance the understanding of diseases and develop new treatment modalities, ensuring that cutting-edge therapies are accessible to the communities it serves. Through its clinical trial initiatives, Methodist Health System aims to contribute to the evolving landscape of medicine while prioritizing patient safety and ethical standards.

Locations

Richardson, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0