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This study was planned and approved just before the 2020 pandemic - once the pandemic resolved, significant changes occurred in the ICU that prevented doing the study - hence it was withdrawn with no patient ever enrolled
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Once a day, up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A3J1 | Canada |
Not at the present time
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Urine collected from a daily 8-hour collection via an indwelling urinary catheter will be used to assess total daily urine volume. Urine samples of 2 ml will be taken and kept in a biomedical laboratory freezer at -80°C to be analyzed in batches every 3 months.
| Up to 14 days |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009104 | Multiple Trauma |
| D000070642 | Brain Injuries, Traumatic |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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