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

Methodist Health System

Status: Completed

Conditions: Stress Ulcer

Treatments: 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.

Study type: Observational

Funder types: Other

Identifiers

NCT06225167

005.PHA.2023.R

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 design

120 participants in 2 patient groups

Protocol Group

Description:

Patients will be analyzed during the time frame of February 2020 to February 2023 for the protocol group

Treatment:

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.

Non Protocol Group

Description:

Patients will be analyzed during the time frame of February 2017 to February 2020 for the non-protocol group.

Treatment:

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.