Patient Important Gastrointestinal Bleeding in the ICU
(PIB Trial)
Trial Summary
What is the purpose of this trial?
This study will engage patients and families to create a definition of what matters most to them about upper gastrointestinal (GI) bleeding. This information will help to define the outcome of "patient-important GI bleeding" which is a secondary endpoint for the ongoing international randomized trial REVISE (NCT03374800), comparing acid suppression versus no acid suppression in the intensive care unit (ICU). Other outcomes in REVISE are clinically important upper GI bleeding, mortality, pneumonia and Clostridioides difficile infection. Guided by patient and family input, a series of open-ended questions will elicit patient and family views about what matters most about this complication in interviews and focus groups. The investigators will develop the definition of "patient-important GI bleeding" by analyzing interview and focus group transcripts of critically ill survivors and family members of critically ill patients who may or may not have had GI bleeding, and who were not enrolled in the REVISE trial. Patient and family perspectives (anticipated to be different from what clinicians consider to be clinically important GI bleeding), will be used to refine a new trial outcome for research on GI bleeding in the intensive care unit (ICU). Also, study results will help clinicians understand how to better support patients and families; to explain testing and treatment options when GI bleeding occurs in practice in the ICU.
Research Team
Eligibility Criteria
Inclusion Criteria
Treatment Details
Interventions
- Patient and Family Interviews and Focus Groups (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Evan Stein
McMaster University
Chief Medical Officer since 2015
MD, PhD
Sam
McMaster University
Chief Executive Officer since 2023
MBA from McMaster University
University of Calgary
Collaborator
Dr. Shweta Patel
University of Calgary
Chief Medical Officer since 2020
MD from the University of Baroda Medical College, India
Dr. Edward McCauley
University of Calgary
President and Vice-Chancellor since 2018
PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara
Canadian Institutes of Health Research (CIHR)
Collaborator
Dr. Paul C. Hébert
Canadian Institutes of Health Research (CIHR)
Chief Executive Officer
MD, University of Ottawa
Dr. Paul C. Hébert
Canadian Institutes of Health Research (CIHR)
Chief Medical Officer
MD, University of Ottawa