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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
Date last updated
15/03/2024

Titles & IDs
Public title
Patient Important Gastrointestinal Bleeding in the ICU
Scientific title
Patient Important Gastrointestinal Bleeding in the ICU
Secondary ID [1] 0 0
PIB_22
Universal Trial Number (UTN)
Trial acronym
PIB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro Intestinal Bleeding 0 0
Diabetes Mellitus 0 0
Patient Engagement 0 0
Family Members 0 0
Ketoacidosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±20% of reference values
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Feasibility of enrolment
Timepoint [2] 0 0
Through study completion; an average of 1 year
Primary outcome [3] 0 0
GI Bleeding characteristics important to patients and families
Timepoint [3] 0 0
Through study completion; an average of 1 year

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2024
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Calgary
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05506150
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05506150