Incidence and Associated Risk Factors of ARC in the Trauma Critically Ill Older Than 50 Years Old
NCT ID: NCT04766944
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-03-31
2025-12-31
Brief Summary
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Detailed Description
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Research hypothesis :
* Critically ill trauma patients aged 50 years or older admitted to the ICU present an augmented renal clearance;
* A set of factors could predict, to a certain extent, the risk of developing ARC in critically ill trauma patients aged 50 years or older admitted to the ICU.
ARC will be assessed for every patient based on daily 8-hour urine collections started within the first 24 hours of ICU admission and daily serum creatinine concentrations. The first seven days will consist of daily urinary collection while only biweekly samples (days 10 and 14) will be collected for the second week. Since ARC is a time-sensitive event, the use of a deferred consent will allow for urine collection to begin as soon as possible after admission. All other data required for the study (demographic and other clinically relevant data) will be collected retrospectively once consent from surrogate or patient has been obtained. Data will be collected from study enrollment up until one of the following events : 1) Day 14 of ICU stay ; 2) ICU discharge; 3) AKI onset; 4) institution of RRT; 5) Removal of urinary catheter; 6) Withdrawal of informed consent; 7) Death; whichever occurs first.
Data regarding demographic variables including age, gender, anthropometric measurements, admission diagnosis, nature of injuries, comorbidities, and length of stay (LOS) will be obtained through the patient's medical records as well as the clinical information system. Data concerning ventilation and 24-hour fluid balance will be obtained through nursing records. Information regarding drug therapy (e.g., vasopressor and antibiotic use) will be obtained through the MUHC software. The Injury Severity Score (ISS) score will be compiled from the local Trauma Registry, while the Sequential Organ Failure Assessment (SOFA) score will be calculated directly.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Critically ill trauma patients of 50 years old and above
Patients of 50 years old and above admitted to the Montreal General Hospital intensive care unit for trauma
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Expected ICU length of stay of more than 24 hours
* Age of ≥ 50 years old at the time of admission
* Serum creatinine ≤ 120 μmol/L at the time of admission
* Presence of an indwelling urinary catheter
* Consent is obtained from the patient or its surrogate decision-maker within 7 days of ICU admission
Exclusion Criteria
* Patient developing acute kidney injury (AKI)
* ICU physician considered patient unsuitable for enrollment due to poor prognosis
* Burn-related trauma
* Patient is admitted \> 48 hours post-traumatic event
50 Years
ALL
Yes
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Marc M. Perreault
Full clinical professor
Locations
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McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2020-6327
Identifier Type: -
Identifier Source: org_study_id