Detailed Assessment of Augmented Renal Clearance in a Large Mixed Intensive Care Unit Population
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Leuven、ベルギー、3000
- 募集
- UZLeuven
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コンタクト:
- Matthias Gijsen, PharmD
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コンタクト:
- Isabel Spriet, PharmD PhD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Having at least one 24h creatinine clearance measurement available
Exclusion Criteria:
- Any form of renal replacement therapy
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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.
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介入なし
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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ARC incidence per day
時間枠:Retrospective analysis between January 2013 and December 2015
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Incidence of ARC per 100 ICU days
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Retrospective analysis between January 2013 and December 2015
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ARC incidence per admission
時間枠:Retrospective analysis between January 2013 and December 2015
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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)
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Retrospective analysis between January 2013 and December 2015
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Duration and course of ARC episodes
時間枠:Retrospective analysis between January 2013 and December 2015
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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)
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Retrospective analysis between January 2013 and December 2015
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ARC daily prevalence
時間枠:Retrospective analysis between January 2013 and December 2015
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Daily prevalence of ARC (% of ARC days per ICU admission day)
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Retrospective analysis between January 2013 and December 2015
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Logistic regression with ARC as dependent variable
時間枠:Retrospective analysis between January 2013 and December 2015
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Risk factors associated with ARC will be identified through logistic regression analysis on demographic and clinical data.
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Retrospective analysis between January 2013 and December 2015
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Predictive algorithm for ARC
時間枠:Retrospective analysis between January 2013 and December 2015
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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.
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Retrospective analysis between January 2013 and December 2015
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Most precise formula using Bland-Altman agreement analysis
時間枠:Retrospective analysis between January 2013 and December 2015
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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).
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Retrospective analysis between January 2013 and December 2015
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Performance of the best cutoff for ARC using ROC curve analysis
時間枠:Retrospective analysis between January 2013 and December 2015
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Performance of the best cutoff for ARC using ROC curve analysis on the most precise formula estimating renal function.
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Retrospective analysis between January 2013 and December 2015
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Exploration of clinical impact of ARC via surrogate markers
時間枠:Retrospective analysis between January 2013 and December 2015
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Vancomycin and aminoglycoside (amikacin & gentamycin) serum concentrations will be used as surrogate markers to evaluate potential clinical impact of ARC.
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Retrospective analysis between January 2013 and December 2015
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協力者と研究者
捜査官
- スタディディレクター:Isabel Spriet, PhD、Universitaire Ziekenhuizen KU Leuven
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
介入なしの臨床試験
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of MichiganNational Institute on Drug Abuse (NIDA)積極的、募集していない
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺