Critical Illness Clinical Trial
Official title:
Incidence and Associated Risk Factors of Augmented Renal Clearance (ARC) in Critically Ill Trauma Patients of 50 Years Old and Above
NCT number | NCT04766944 |
Other study ID # | 2020-6327 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | December 2025 |
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Admission to the ICU for isolated traumatic brain injury (TBI), polytrauma without TBI or combined polytrauma and TBI - 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: - History of renal replacement therapy (RRT) (intermittent dialysis or peritoneal dialysis), nephrectomy or renal transplant - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. |
Up to 14 days |
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