Detailed Assessment of Augmented Renal Clearance in a Large Mixed Intensive Care Unit Population
1 other identifier
observational
10,000
1 country
1
Brief Summary
This multi-center retrospective cohort study presents a detailed assessment of augmented renal clearance (ARC) in a mixed population of adult critically ill patients. Epidemiology of ARC will be studied in detail in a very heterogeneous population. Risk factors for ARC will be identified and a predictive scoring system for ARC ready to use in clinical practice will be constructed and validated. Performance of estimators of kidney function will be measured and a cutoff for ARC will be determined for the best estimator. Finally clinical impact of ARC will be explored using vancomycine and aminoglycosides levels as surrogate marker.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 17, 2019
May 1, 2019
10 months
May 3, 2019
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (9)
ARC incidence per day
Incidence of ARC per 100 ICU days
Retrospective analysis between January 2013 and December 2015
ARC incidence per admission
Incidence of ARC in % of ICU admissions: with ARC incidence defined as at least once, min. 50% of the measurements, 100% of the measurements during ICU admission)
Retrospective analysis between January 2013 and December 2015
Duration and course of ARC episodes
ARC episodes: number of episodes (count), length of the episodes (days) and both combined to obtain relative contribution to ARC as a % ((count\*length)/total ARC days)
Retrospective analysis between January 2013 and December 2015
ARC daily prevalence
Daily prevalence of ARC (% of ARC days per ICU admission day)
Retrospective analysis between January 2013 and December 2015
Logistic regression with ARC as dependent variable
Risk factors associated with ARC will be identified through logistic regression analysis on demographic and clinical data.
Retrospective analysis between January 2013 and December 2015
Predictive algorithm for ARC
An algorithm predicting ARC on the next day(s) will be created using a backward selection logistic regression model on the risk factors associated with ARC detected in this study and/or in previously published studies.
Retrospective analysis between January 2013 and December 2015
Most precise formula using Bland-Altman agreement analysis
Bland-Altman agreement analysis between CrCl24h and 3 commonly used serum creatinine based formulae estimating renal function (CKD-EPI, C\&G, MDRD) will be used to identify the formula with the best precision (SD of the bias).
Retrospective analysis between January 2013 and December 2015
Performance of the best cutoff for ARC using ROC curve analysis
Performance of the best cutoff for ARC using ROC curve analysis on the most precise formula estimating renal function.
Retrospective analysis between January 2013 and December 2015
Exploration of clinical impact of ARC via surrogate markers
Vancomycin and aminoglycoside (amikacin \& gentamycin) serum concentrations will be used as surrogate markers to evaluate potential clinical impact of ARC.
Retrospective analysis between January 2013 and December 2015
Study Arms (1)
Critically ill patients with a CrCl24h
Patients admitted to any intensive care unit (surgical, medical or cardiac) and having at least one 24h creatinine clearance measurement available.
Interventions
Eligibility Criteria
Patients admitted at any intensive care unit (surgical, medical, cardiac) from the 3 participating centra (Leuven University Hospitals, Ghent University Hospital, Antwerp University Hospital) between 2013 and present
You may qualify if:
- Having at least one 24h creatinine clearance measurement available
You may not qualify if:
- Any form of renal replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- University Hospital, Ghentcollaborator
- University Hospital, Antwerpcollaborator
Study Sites (1)
UZLeuven
Leuven, 3000, Belgium
Related Publications (1)
Gijsen M, Huang CY, Flechet M, Van Daele R, Declercq P, Debaveye Y, Meersseman P, Meyfroidt G, Wauters J, Spriet I. Development and External Validation of an Online Clinical Prediction Model for Augmented Renal Clearance in Adult Mixed Critically Ill Patients: The Augmented Renal Clearance Predictor. Crit Care Med. 2020 Dec;48(12):e1260-e1268. doi: 10.1097/CCM.0000000000004667.
PMID: 33048900DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabel Spriet, PhD
Universitaire Ziekenhuizen KU Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 17, 2019
Study Start
October 1, 2018
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
May 17, 2019
Record last verified: 2019-05