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Trial record 89 of 530 for:    VANCOMYCIN

Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry (VCMTDMinCI)

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ClinicalTrials.gov Identifier: NCT02896218
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Qinggang GE, Peking University Third Hospital

Brief Summary:
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). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. 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 based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

Condition or disease Intervention/treatment
Critically Ill Other: Pharmacists consultation

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Month
Official Title: Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Pharmacists consultation
Pharmacists consultation of vancomycin individualized dosing strategy

Usual care group
Empirical use of vancomycin without pharmacists consultation.



Primary Outcome Measures :
  1. The rate of treatment failure [ Time Frame: 2016-9 to 2018-1 ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 2016-9 to 2018-1 ]
  2. Mortality caused by infections [ Time Frame: 2016-9 to 2018-1 ]
  3. Mortality caused by gram-positive infections [ Time Frame: 2016-9 to 2018-1 ]
  4. Adverse events related to vancomycin [ Time Frame: 2016-9 to 2018-1 ]
  5. Nephrotoxicity related to vancomycin [ Time Frame: 2016-9 to 2018-1 ]

    According to KDIGO, AKI is defined by any of the following:

    • Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours; or
    • Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days; or
    • Urine volume <0.5 mL/kg/h for six hours.

    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.


  6. Cost-effectiveness of pharmacist intervention [ Time Frame: 2016-9 to 2018-1 ]
    The outcome is the incremental cost of preventing one treatment failure infection-related mortality or nephrotoxicity.

  7. Duration of using ventilator [ Time Frame: 2016-9 to 2018-1 ]
  8. Vancomycin dosage [ Time Frame: -2016-9 to 201 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896218


Contacts
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Contact: Qinggang Ge, M.D. qingganggelin@126.com
Contact: Yingying YAN, Ph.D. yanyingying89@163.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Qinggang Ge, M.D.       qingganggelin@126.com   
Contact: Yingying Yan, Ph.D.       yanyingying89@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Qinggang Ge, M.D. Peking University Third Hospital

Additional Information:

Publications:

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Responsible Party: Qinggang GE, M.D. Chief physician, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT02896218     History of Changes
Other Study ID Numbers: CM-001
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Qinggang GE, Peking University Third Hospital:
Vancomycin
Critically Ill
Pharmacist
Population Pharmacokinetic
Bayesian Methods
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents