Nctid:
NCT06225167
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014456", "term"=>"Ulcer"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M17206", "name"=>"Ulcer", "asFound"=>"Ulcer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>120}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-05-13", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-07-17", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-03-26", "studyFirstSubmitDate"=>"2023-07-06", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-07-17", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"compare the incidence of overt GI bleeds", "timeFrame"=>"24 hours", "description"=>"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."}], "secondaryOutcomes"=>[{"measure"=>"Identify the acid suppressive therapy reorder rate", "timeFrame"=>"24 hours", "description"=>"To Identify the acid suppressive therapy reorder frequency"}, {"measure"=>"Number of doses avoided", "timeFrame"=>"24 hours", "description"=>"Number of acid suppressive therapy doses avoided"}, {"measure"=>"Incidences of hospital acquired pneumonia (HAP)", "timeFrame"=>"24 hours", "description"=>"Number of HAP cases occurring"}, {"measure"=>"Incidences of C.Difficile infection", "timeFrame"=>"24 hours", "description"=>"Number of cases of C.Difficile infections occurring"}, {"measure"=>"ICU length of stay", "timeFrame"=>"24 hours", "description"=>"The time frame of ICU stay"}, {"measure"=>"incidence of ICU delirium", "timeFrame"=>"24 hours", "description"=>"number of cases with ICU Delirium"}, {"measure"=>"type of pharmacologic agent used", "timeFrame"=>"24 hours", "description"=>"Different types of medications used"}, {"measure"=>"number of patients with clinically important GI bleeding", "timeFrame"=>"24 hours", "description"=>"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."}, {"measure"=>"number of discharge prescriptions for acid suppressive therapy", "timeFrame"=>"24 hours", "description"=>"number of patients getting discharged with acid suppressive therapy"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Stress Ulcer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"29949497", "type"=>"BACKGROUND", "citation"=>"Cook D, Guyatt G. Prophylaxis against Upper Gastrointestinal Bleeding in Hospitalized Patients. N Engl J Med. 2018 Jun 28;378(26):2506-2516. doi: 10.1056/NEJMra1605507. No abstract available."}, {"pmid"=>"8284001", "type"=>"BACKGROUND", "citation"=>"Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. doi: 10.1056/NEJM199402103300601."}, {"pmid"=>"10690219", "type"=>"BACKGROUND", "citation"=>"ASHP Therapeutic Guidelines on Stress Ulcer Prophylaxis. ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998. Am J Health Syst Pharm. 1999 Feb 15;56(4):347-79. doi: 10.1093/ajhp/56.4.347. No abstract available."}, {"type"=>"BACKGROUND", "citation"=>"4. Guillamondegui OD, et al. Practice management guidelines for stress ulcer prophylaxis. Eastern Association for the Surgery of Trauma (EAST); 2008."}, {"pmid"=>"35777844", "type"=>"BACKGROUND", "citation"=>"Saeed M, Bass S, Chaisson NF. Which ICU patients need stress ulcer prophylaxis? Cleve Clin J Med. 2022 Jul 1;89(7):363-367. doi: 10.3949/ccjm.89a.21085."}, {"pmid"=>"15143910", "type"=>"BACKGROUND", "citation"=>"Kantorova I, Svoboda P, Scheer P, Doubek J, Rehorkova D, Bosakova H, Ochmann J. Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. Hepatogastroenterology. 2004 May-Jun;51(57):757-61."}, {"pmid"=>"20711074", "type"=>"BACKGROUND", "citation"=>"Marik PE, Vasu T, Hirani A, Pachinburavan M. Stress ulcer prophylaxis in the new millennium: a systematic review and meta-analysis. Crit Care Med. 2010 Nov;38(11):2222-8. doi: 10.1097/CCM.0b013e3181f17adf."}, {"pmid"=>"27635481", "type"=>"BACKGROUND", "citation"=>"Selvanderan SP, Summers MJ, Finnis ME, Plummer MP, Ali Abdelhamid Y, Anderson MB, Chapman MJ, Rayner CK, Deane AM. Pantoprazole or Placebo for Stress Ulcer Prophylaxis (POP-UP): Randomized Double-Blind Exploratory Study. Crit Care Med. 2016 Oct;44(10):1842-50. doi: 10.1097/CCM.0000000000001819."}, {"pmid"=>"31988751", "type"=>"BACKGROUND", "citation"=>"Ogasawara O, Kojima T, Miyazu M, Sobue K. Impact of the stress ulcer prophylactic protocol on reducing the unnecessary administration of stress ulcer medications and gastrointestinal bleeding: a single-center, retrospective pre-post study. J Intensive Care. 2020 Jan 16;8:10. doi: 10.1186/s40560-020-0427-8. eCollection 2020."}, {"type"=>"BACKGROUND", "citation"=>"11. Dhand, ND, Khatkar MS (2014). Statulator: An online statistical calculator. Sample Size Calculator for Comparing Two Independent Proportions. Accessed 16 March 2023 at http://statulator.com/SampleSize/ss2P.html."}]}, "descriptionModule"=>{"briefSummary"=>"Pharmacologic stress ulcer prophylaxis is routinely used in the intensive care unit (ICU) to prevent upper gastrointestinal (GI) bleeding in critically ill patients.", "detailedDescription"=>"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.\n\nAcid 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients ≥18 years ICU location status stress ulcer prophylaxis in ICU patients when it is no longer indicated according to pre-defined criteria.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients ≥18 years ICU location status\n\nExclusion Criteria:\n\n* If patient has one of the following:\n\n * Coagulopathy (defined as: platelets \\< 50,000/µL, international normalized ratio(INR) \\> 1.5, or partial thromboplastin time \\> 2 times the control value)\n * Mechanical ventilation for \\> 48 hours and on \\< 50% goal tube feeds\n * Shock state on vasopressors/inotropes and on \\< 50% goal tube feeds (or \\< 50% of diet)\n * On total parenteral nutrition\n * Use of acid suppressive therapy prior to admission\n * Admission with GI bleeding\n * History of peptic ulcer disease\n * Surgery on the GI tract or cardiac surgery during the current hospital admission\n * Pregnancy\n * H. pylori infection treatment\n * Hypersecretory disorder (ex: Zollinger-Ellison)\n * Known erosive esophagitis/gastritis (not heartburn or gastroesophageal reflux disease)\n * Traumatic brain injury with Glasgow Coma Scale score ≤ 10\n * Major burn (˃30% body surface area)\n * Major trauma requiring ICU admission\n * Spinal cord injury requiring ICU admission\n\nIf patient has two or more of the following:\n\n* Administration of ˃ 100 mg daily of prednisolone (or equivalent)\n* Sepsis\n* Acute renal failure\n* Acute hepatic failure"}, "identificationModule"=>{"nctId"=>"NCT06225167", "briefTitle"=>"Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit", "organization"=>{"class"=>"OTHER", "fullName"=>"Methodist Health System"}, "officialTitle"=>"Pharmacist-Driven Stress Ulcer Prophylaxis Minimization in the Intensive Care Unit", "orgStudyIdInfo"=>{"id"=>"005.PHA.2023.R"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Protocol Group", "description"=>"Patients will be analyzed during the time frame of February 2020 to February 2023 for the protocol group", "interventionNames"=>["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."]}, {"label"=>"Non Protocol Group", "description"=>"Patients will be analyzed during the time frame of February 2017 to February 2020 for the non-protocol group.", "interventionNames"=>["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."]}], "interventions"=>[{"name"=>"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.", "type"=>"BEHAVIORAL", "description"=>"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.\n\nTo 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.", "armGroupLabels"=>["Non Protocol Group", "Protocol Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75082", "city"=>"Richardson", "state"=>"Texas", "country"=>"United States", "facility"=>"Methodist Richardson Medical Center", "geoPoint"=>{"lat"=>32.94818, "lon"=>-96.72972}}], "overallOfficials"=>[{"name"=>"Heidi Michaels, PharmD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Methodist Health System"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR", "ANALYTIC_CODE"], "timeFrame"=>"3 years", "ipdSharing"=>"YES", "description"=>"Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.", "accessCriteria"=>"Clinical Research Institute"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Methodist Health System", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
