An observational study in Augmented Renal Clearance, Critical Illness and Polytrauma, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Withdrawn at 1 site in Canada. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
This single-center prospective cohort study conducted at the adult trauma ICU of the Montreal General Hospital (MGH) affiliated with the McGill University Health Centre (MUHC) aims to determine the incidence and associated risk factors of augmented renal clearance (ARC) in critically ill trauma patients of 50 years old and above.
Patients aged 50 years or older admitted to the ICU for traumatic brain injury (TBI) and/or polytrauma between January 2021 and October 2021 will be screened for study enrollment according to inclusion and exclusion criteria.
Research hypothesis :
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.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
Browse Multiple Trauma studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
Compared within Multiple Trauma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients aged 50 years old or older admitted to the ICU for traumatic brain injury (TBI) and/or polytrauma between January 2021 and October 2021
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Exclusion Criteria:
Patients of 50 years old and above admitted to the Montreal General Hospital intensive care unit for trauma
Other: No intervention
No intervention
To determine the incidence of augmented renal clearance in critically ill trauma patients aged 50 years and older
The incidence of augmented renal clearance is dichotomic: presence or absence of augmented renal clearance defined as a creatinine clearance of ≥ 130 mL/min/m² measured by a daily 8 hour urine collection
Time frame: Once a day, up to 14 days
To determine demographic and clinical risk factors for ARC in critically ill trauma patients aged 50 years and older
Predictive variables of ARC to be included in the model include: age strata (50-59 years old, 60-69 years old, 70 years old and above; biological gender; type of trauma (TBI, polytrauma without TBI, combined polytrauma and TBI) and severity of trauma (Injury Severity Score (ISS score), Sequential Organ Failure Assessment (SOFA) score, severity of TBI (GSC score at admission). Other variables to be included in the model will depend on the number of cases observed with a minimum of 10 cases per variable.
Time frame: Up to 14 days
Plan to share: Undecided — Not at the present time
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Dec 2024, 9 months later.
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This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →