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OpenTrials
Completed

NCT Number: NCT06225167

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. compare the incidence of overt GI bleeds

    Time frame: 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 outcomes

  1. Identify the acid suppressive therapy reorder rate

    Time frame: 24 hours

    To Identify the acid suppressive therapy reorder frequency

  2. Number of doses avoided

    Time frame: 24 hours

    Number of acid suppressive therapy doses avoided

  3. Incidences of hospital acquired pneumonia (HAP)

    Time frame: 24 hours

    Number of HAP cases occurring

  4. Incidences of C.Difficile infection

    Time frame: 24 hours

    Number of cases of C.Difficile infections occurring

  5. ICU length of stay

    Time frame: 24 hours

    The time frame of ICU stay

  6. incidence of ICU delirium

    Time frame: 24 hours

    number of cases with ICU Delirium

  7. type of pharmacologic agent used

    Time frame: 24 hours

    Different types of medications used

  8. number of patients with clinically important GI bleeding

    Time frame: 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.

  9. number of discharge prescriptions for acid suppressive therapy

    Time frame: 24 hours

    number of patients getting discharged with acid suppressive therapy

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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