Augmented Renal ClearanceNCT04766944
Incidence and Associated Risk Factors of ARC in the Trauma Critically Ill Older Than 50 Years Old
An observational study of Augmented Renal Clearance and Critical Illness, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Augmented Renal Clearance, Critical Illness, Polytrauma
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Augmented renal clearance, Critical illness, Critical care, Intensive care unit, Trauma, Polytrauma, Traumatic brain injury, Elderly, Middle-aged
- Medical subject headings
- Critical Illness, Multiple Trauma, Brain Injuries, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented Renal ClearanceStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc M. Perreault, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766944
- Sponsor's protocol ID
- 2020-6327
- Status last verified
- Dec 2024
- First submitted
- 14 Feb 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not at the present time
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Associated Risk Factors of Augmented Renal Clearance (ARC) in Critically Ill Trauma Patients of 50 Years Old and Above
- ClinicalTrials.gov ID
- NCT04766944
- Acronym / sponsor ID
- 2020-6327
- Keywords
- Augmented renal clearance, Critical illness, Critical care, Intensive care unit, Trauma, Polytrauma, Traumatic brain injury, Elderly
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill trauma patients of 50 years old and above | – | Other: No interventionPatients of 50 years old and above admitted to the Montreal General Hospital intensive care unit for trauma |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Critically ill trauma patients of 50 years old and above |
Primary outcome
To determine the incidence of augmented renal clearance in critically ill trauma patients aged 50 years and older
Time frame: Once a day, up to 14 days
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
1 secondary outcome
To determine demographic and clinical risk factors for ARC in critically ill trauma patients aged 50 years and older
Time frame: Up to 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided. Not at the present time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Augmented Renal Clearance and Critical Illness, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of augmented renal clearance in critically ill trauma patients aged 50 years and older (time frame: Once a day, up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.