- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03954275
Detailed Assessment of Augmented Renal Clearance in a Large Mixed Intensive Care Unit Population
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Augmented renal clearance will be assessed in detail in a very large and heterogeneous adult critically ill population. Analysis will be conducted retrospectively on a multi-center database collected by the M@tric research group. M@tric collects data from all intensive care units (surgical, medical, cardiac) in 3 Belgian University Hospitals (Leuven, Ghent, Antwerp).
Anonymised admission, demographic, clinical and laboratory data collected from 2013 until the present will be retrieved from the M@tric database. These data will then be coded and analysed in R statistical software. ARC will be defined based on a 24h creatinine clearance (CrCl24h) >=130ml/min/1.73m².
Epidemiology and risk factors for ARC will be studied in order to confirm and clarify past studies which have mostly been done in rather small and specific subsets of patients. A predictive algorithm for ARC will be trained and subsequently validated for use in clinical practice. Moreover this algorithm will be compared to existing scoring systems, which have not yet found their way into clinical practice. This algorithm will provide the ability to anticipate ARC on the intensive care unit. Also use of formulae estimating renal function will be evaluated in this population. These estimators will be compared to the CrCl24h, which is considered the golden standard in clinical practice. A cutoff for the best estimating formula in order to detect ARC will be calculated. Finally the impact of ARC on serum levels of hydrophilic molecules likes vancomycine and aminoglycosides will be studied. As this research follows a retrospective design these levels will be used a surrogate marker for clinical impact. This will potentially point out some opportunities for future research on the clinical impact of ARC.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Matthias Gijsen, PharmD
- Telefonnummer: 0032 16 340087
- E-Mail: matthias.gijsen@uzleuven.be
Studieren Sie die Kontaktsicherung
- Name: Isabel Spriet, PhD
- Telefonnummer: 0032 16 341262
- E-Mail: isabel.spriet@uzleuven.be
Studienorte
-
-
-
Leuven, Belgien, 3000
- Rekrutierung
- UZLeuven
-
Kontakt:
- Matthias Gijsen, PharmD
-
Kontakt:
- Isabel Spriet, PharmD PhD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Having at least one 24h creatinine clearance measurement available
Exclusion Criteria:
- Any form of renal replacement therapy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
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.
|
kein Eingriff
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
ARC incidence per day
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
Incidence of ARC per 100 ICU days
|
Retrospective analysis between January 2013 and December 2015
|
ARC incidence per admission
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
Zeitfenster: Retrospective analysis between January 2013 and December 2015
|
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
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Isabel Spriet, PhD, Universitaire Ziekenhuizen KU Leuven
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- S61364
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Kritische Krankheit
-
Charite University, Berlin, GermanyReactive Robotics GmbHAbgeschlossenKritische Krankheit | Rehabilitation | Frühe Gehfähigkeit | Critical Illness PolyneuromyopathieDeutschland
-
Adana City Training and Research HospitalAbgeschlossenCritical Illness PolyneuromyopathieTruthahn
-
University of AthensUnbekanntCritical-Illness-Polyneuromyopathie (CIPNM) | Auf der Intensivstation erworbene Schwäche (ICUAW)Griechenland
-
Hospital de Clinicas de Porto AlegreUnbekanntCritical Illness PolyneuropathienBrasilien
-
Charite University, Berlin, GermanyReactive Robotics GmbHAbgeschlossenKritische Krankheit | Covid19 | Rehabilitation | Robotik | Frühmobilisierung | Critical Illness PolyneuromyopathieDeutschland
-
Koç UniversityAbgeschlossenCOVID-19 | Rehabilitation | Akutes Lungenversagen | Erworbene Schwäche auf der Intensivstation | Critical Illness PolyneuromyopathieTruthahn
Klinische Studien zur kein Eingriff
-
RTI InternationalNo Means No WorldwideAbgeschlossenSexuelle Gewalt | Geschlechtsspezifische GewaltSüdafrika
-
University of Illinois at ChicagoUniversity of Chicago; The Broad FoundationAbgeschlossenColitis ulcerosaVereinigte Staaten
-
King's College LondonMedical University of Graz; Radboud University Medical Center; Novo Nordisk A/S; Juvenile Diabetes Research Foundation und andere MitarbeiterAbgeschlossenDiabetes mellitus, Typ 2 | Hypoglykämie | Diabetes mellitus, Typ 1 | Hypoglykämie-WahrnehmungsstörungVereinigtes Königreich
-
Otsuka Pharmaceutical Factory, Inc.CelerionAbgeschlossen
-
Universitat Jaume IAbgeschlossen
-
Seoul National University HospitalSamsung Medical Center; Chosun University HospitalBeendetRadiofrequenz-Ablation | Mikrowellen-AblationKorea, Republik von
-
University of MinnesotaAbgeschlossen
-
University of ValenciaHospital de la RiberaUnbekannt
-
China National Center for Cardiovascular DiseasesUnbekannt
-
Catharina Ziekenhuis EindhovenAbgeschlossen