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

NCT04766944 | Withdrawn

• 1 other identifier: 2020-6327
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Augmented Renal Clearance; Critical Illness; Polytrauma; Traumatic Brain Injury

Keywords

Augmented renal clearance; Critical illness; Critical care; Intensive care unit; Trauma; Polytrauma; Traumatic brain injury; Elderly; Middle-aged

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine demographic and clinical risk factors for ARC in critically ill trauma patients aged 50 years and older

  Up to 14 days

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

Critically ill trauma patients of 50 years old and above

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Critical Illness; Multiple Trauma; Brain Injuries, Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full clinical professor

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CA (1)