- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02896218
Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry (VCMTDMinCI)
Studieoversigt
Detaljeret beskrivelse
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.
This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100191
- Rekruttering
- Peking University Third Hospital
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Kontakt:
- Qinggang Ge, M.D.
- E-mail: qingganggelin@126.com
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Kontakt:
- Yingying Yan, Ph.D.
- E-mail: yanyingying89@163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The prospective cohort: all patients in this cohort will receive pharmacist consultation when prescribed vancomycin.
The retrospective cohort: patients in this cohort received usual care from JAN 2010 to MAR 2015; patients in this cohort received pharmacist consultation from APR 2016 to JUL 2016.
Beskrivelse
Inclusion Criteria:
- Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN 2010.
- Receiving vancomycin therapy for 72 hours or more.
- Aged ≥ 18 years.
Exclusion Criteria:
- Administration of vancomycin in non-intravenous access.
- Life expectancy of less than 24 hours.
- Pregnancy women.
- Presence of immunodeficiency.
- Presence of hematological disorder.
- Written informed consent not obtained in the prospective cohort.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Pharmacist consulting group
When physicians make the decision that patients need to prescribe vancomycin or need dose adjustment, they will call for a pharmacist consultation.
Pharmacists will provide the initial regimen based on PPK methods if applicable, otherwise give the suggestion of the initial dosage according to guidelines.
Also, pharmacists will give suggestions on the time of sampling for serum concentration measurement.
For dosage adjustment, pharmacists will be informed the results of serum vancomycin concentration, and then make a calculation using Bayesian estimation to determine whether there is a necessity to change the dosing regimen.
Pharmacists will follow the patients until they discharge.
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Pharmacists consultation of vancomycin individualized dosing strategy
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Usual care group
Empirical use of vancomycin without pharmacists consultation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The rate of treatment failure
Tidsramme: 2016-9 to 2018-1
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2016-9 to 2018-1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
All cause mortality
Tidsramme: 2016-9 to 2018-1
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2016-9 to 2018-1
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Mortality caused by infections
Tidsramme: 2016-9 to 2018-1
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2016-9 to 2018-1
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Mortality caused by gram-positive infections
Tidsramme: 2016-9 to 2018-1
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2016-9 to 2018-1
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Adverse events related to vancomycin
Tidsramme: 2016-9 to 2018-1
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2016-9 to 2018-1
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Nephrotoxicity related to vancomycin
Tidsramme: 2016-9 to 2018-1
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According to KDIGO, AKI is defined by any of the following:
All adverse events will be assessed and analyzed with WHO-UMC causality criteria by investigators. Adverse events related to vancomycin, especially nephrotoxicity, will be analyzed. |
2016-9 to 2018-1
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Cost-effectiveness of pharmacist intervention
Tidsramme: 2016-9 to 2018-1
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The outcome is the incremental cost of preventing one treatment failure infection-related mortality or nephrotoxicity.
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2016-9 to 2018-1
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Duration of using ventilator
Tidsramme: 2016-9 to 2018-1
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2016-9 to 2018-1
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Vancomycin dosage
Tidsramme: -2016-9 to 201
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-2016-9 to 201
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Qinggang Ge, M.D., Peking University Third Hospital
Publikationer og nyttige links
Generelle publikationer
- Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC Jr, Craig WA, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adults summary of consensus recommendations from the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2009 Nov;29(11):1275-9. doi: 10.1592/phco.29.11.1275.
- Ye ZK, Chen YL, Chen K, Zhang XL, Du GH, He B, Li DK, Liu YN, Yang KH, Zhang YY, Zhai SD; Guideline Steering Group, the Guideline Development Group and the Guideline Secretary Group. Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. J Antimicrob Chemother. 2016 Nov;71(11):3020-3025. doi: 10.1093/jac/dkw254. Epub 2016 Jul 11.
- Matsumoto K, Takesue Y, Ohmagari N, Mochizuki T, Mikamo H, Seki M, Takakura S, Tokimatsu I, Takahashi Y, Kasahara K, Okada K, Igarashi M, Kobayashi M, Hamada Y, Kimura M, Nishi Y, Tanigawara Y, Kimura T. Practice guidelines for therapeutic drug monitoring of vancomycin: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. J Infect Chemother. 2013 Jun;19(3):365-80. doi: 10.1007/s10156-013-0599-4. Epub 2013 May 15. No abstract available.
- Pea F, Bertolissi M, Di Silvestre A, Poz D, Giordano F, Furlanut M. TDM coupled with Bayesian forecasting should be considered an invaluable tool for optimizing vancomycin daily exposure in unstable critically ill patients. Int J Antimicrob Agents. 2002 Nov;20(5):326-32. doi: 10.1016/s0924-8579(02)00188-7.
- Smith C, Burley C, Ireson M, Johnson T, Jordan D, Knight S, Mason T, Massey D, Moss J, Williams K. Clinical trials of antibacterial agents: a practical guide to design and analysis. Statisticians in the Pharmaceutical Industry Working Party. J Antimicrob Chemother. 1998 Apr;41(4):467-80. doi: 10.1093/jac/41.4.467.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CM-001
Plan for individuelle deltagerdata (IPD)
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