Stress Ulcer
Conditions
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.
Interventions
BEHAVIORALTo 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 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.
Sponsors
Methodist Health System
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Identify the acid suppressive therapy reorder rate | 24 hours | To Identify the acid suppressive therapy reorder frequency |
| Number of doses avoided | 24 hours | Number of acid suppressive therapy doses avoided |
| Incidences of hospital acquired pneumonia (HAP) | 24 hours | Number of HAP cases occurring |
| 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 |
| 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. |
| number of discharge prescriptions for acid suppressive therapy | 24 hours | number of patients getting discharged with acid suppressive therapy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeidi Michaels, PharmD
Methodist Health System
Outcome results
None listed