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

Completed

• Conditions: Stress Ulcer
• Interventions: 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.

• Registration Number: NCT06225167
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study Start: 2023-05-13
• Study First Submitted: 2023-07-06
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-17
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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.	Patients will be analyzed during the time frame of February 2017 to February 2020 for the non-protocol group.
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.	Patients will be analyzed during the time frame of February 2020 to February 2023 for the protocol group

Primary Outcome Measures

Name	Time	Method
compare the incidence of overt GI bleeds	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Number of doses avoided	24 hours	Number of acid suppressive therapy doses avoided
Incidences of C.Difficile infection	24 hours	Number of cases of C.Difficile infections occurring
ICU length of stay	24 hours	The time frame of ICU stay
incidence of ICU delirium	24 hours	number of cases with ICU Delirium
type of pharmacologic agent used	24 hours	Different types of medications used
Identify the acid suppressive therapy reorder rate	24 hours	To Identify the acid suppressive therapy reorder frequency
Incidences of hospital acquired pneumonia (HAP)	24 hours	Number of HAP cases occurring
number of discharge prescriptions for acid suppressive therapy	24 hours	number of patients getting discharged with acid suppressive therapy
number of patients with clinically important GI bleeding	24 hours	Bleeding defined as overt GI bleeding plus one or more of the following within 24 hours such as decrease in systolic pressure, mean arterial pressure or diastolic pressure, orthostatic hypotension or postural tachycardia , drop in hemoglobin, received transfusions of packed red blood cells or need for vasopressors or invasive interventions like endoscopy.

Trial Locations

Locations (1)

Methodist Richardson Medical Center; 🇺🇸 Richardson, Texas, United States