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

Incidence and Associated Risk Factors of Augmented Renal Clearance (ARC) in Critically Ill Trauma Patients of 50 Years Old and Above

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Traumatic Brain Injury; Polytrauma; Augmented Renal Clearance
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Marc Perreault, PharmD; Phone Number: 3788 514-343-6111; Email: marc.perreault@umontreal.ca
• Study Contact Backup: Name: Marc-Alexandre Duceppe, PharmD; Phone Number: 43325 514-934-1934; Email: marc-alexandre.duceppe@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A3J1
      • McGill University Health Centre
      • Contact: Marc M Perreault, MSc; Phone Number: 3788 514-343-6111; Email: marc.perreault@umontreal.ca
      • Contact: Marc-Alexandre Duceppe, MSc; Phone Number: 43325 514-934-1934; Email: marc-alexandre.duceppe@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Up to 14 days

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2024
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Intensive care unit; Critical illness; Critical care; Traumatic brain injury; Trauma; Polytrauma; Augmented renal clearance; Middle-aged
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Critical Illness; Multiple Trauma
• Other Study ID Numbers: 2020-6327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not at the present time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No