Incidence and Associated Risk Factors of ARC in the Trauma Critically Ill Older Than 50 Years Old

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04766944
• Other study ID #: 2020-6327
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Marc Perreault, PharmD
• Phone: 514-343-6111
• Email: marc.perreault[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 : - 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Augmented Renal Clearance
• Brain Injuries
• Brain Injuries, Traumatic
• Critical Illness
• Multiple Trauma
• Polytrauma
• Traumatic Brain Injury

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

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