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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05506150
Registration number
NCT05506150
Ethics application status
Date submitted
16/08/2022
Date registered
18/08/2022
Titles & IDs
Public title
Patient Important Gastrointestinal Bleeding in the ICU
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Scientific title
Patient Important Gastrointestinal Bleeding in the ICU
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Secondary ID [1]
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PIB_22
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Universal Trial Number (UTN)
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Trial acronym
PIB
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastro Intestinal Bleeding
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Diabetes Mellitus
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Patient Engagement
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Family Members
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Ketoacidosis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
BEHAVIORAL - Interviews
BEHAVIORAL: Interviews
Focused conversations to understand features of a GI bleed that are important to patients and families.
Patients and family members are invited to participate in focused conversations. For interviews and focus groups, criterion sampling will be used. Investigators employed qualitative and quantitative methods to collect and analyze data. Quantitative data includes self-reported demographic characteristics of the patient and family members. Qualitative data about participants will be obtained through individual interviews and focused groups and project team field notes.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±20% of reference values
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Assessment method [1]
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At least 98% of values should be within ±20% of reference values (laboratory method) for glucose concentration =75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \< 75 mg/dL(4.16 mmol/L).
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Timepoint [1]
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12 weeks
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Primary outcome [2]
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Feasibility of enrolment
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Assessment method [2]
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Enrolment will be deemed feasible when the following criteria are met: a) at least 15 surviving critically ill patients and 15 family members have been recruited; b) at least 8 focus groups have been completed; c) Representation of patients and families from several regions served by academic health sciences centres; 4) 80% participation rate for invited patients and families
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Timepoint [2]
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Through study completion; an average of 1 year
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Primary outcome [3]
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GI Bleeding characteristics important to patients and families
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Assessment method [3]
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While clinically important GI bleeding is defined in research as bleeding accompanied by hemodynamic consequences, red blood cell transfusions or other invasive interventions, the concept of patient-important upper GI bleeding has not been developed for the ICU. In this study, the investigators will elicit views using open-ended questions about the tests and treatments about GI bleeding of greatest concern. This information will be analyzed inductively to develop and/or refine a new patient-centred definition of important bleeding. The investigators hypothesize that the GI bleed characteristics which are relevant to patients and families will not be the same as those relevant to clinicians. The inductive analysis involves the generation of categories and domains directly from the data, without pre-conceived notions of what these categories or domains might be.
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Timepoint [3]
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Through study completion; an average of 1 year
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Eligibility
Key inclusion criteria
Patient
* Was admitted to an ICU, whether or not a GI bleed developed in the ICU
* > 18 years of age
Family Member
* Family members of ICU patients whose loved one was in the ICU for at least 72 hours, whether or not their family member developed a GI bleed
* > 18 years of age
Patient/Family Member
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prohibitive communication challenges (e.g., serious psychological or psychiatric illness in the patient and/or family, inability of patient and/or family to communicate reasonably well in English or other languages for which an interpreter exists - professional staff or otherwise);
* Patient or family declines.
* Family member whose loved one died in ICU
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/01/2024
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Calgary
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05506150
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Per the research ethics board-approved protocol, participants did not agree to data sharing (qualitative or quantitative)
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05506150