UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024321 |
|---|---|
| Receipt number | R000028012 |
| Scientific Title | Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2021/04/10 09:47:00 |
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Basic information
Public title
Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Acronym
Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Scientific Title
Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Scientific Title:Acronym
Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To individualize antimicrobial dose by clarifying pharmacokinetics in patients undergoing blood purification therapy.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To develop population pharmacokinetic model
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 150 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Undergoing blood purification therapy
Key exclusion criteria
In state with impossible sampling of blood for measurement of blood antimicrobial concentration
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Saito |
Organization
Kumamoto University Hospital
Division name
Department of Pharmacy
Zip code
860-8556
Address
1-1-1, Honjo, ChuoKu, Kumamoto city, Kumamoto Pref.
TEL
096-373-5820
saitohide@fc.kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Oda |
Organization
Kumamoto University Hospital
Division name
Department of Pharmacy
Zip code
860-8556
Address
1-1-1, Honjo, ChuoKu, Kumamoto city, Kumamoto Pref.
TEL
096-373-7457
Homepage URL
kazutakaoda-kuh@umin.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital
Address
1-1-1, Honjo, ChuoKu, Kumamoto city, Kumamoto Pref.
Tel
096-373-5657
iyg-igaku@jimu.kumamoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028012
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11095-020-02820-0
Number of participants that the trial has enrolled
40
Results
In vancomycin-administered-patients with continuous blood purification therapy, we identified reduced urine output (RUO, <0.5 ml/kg/h) and effluent flow rate were the factor for the vancomycin clearance. Using the pharmacokinetic model, The compliance rate for therapeutic trough concentration by the Bayesian estimation was higher (87.0%) than that by a conventional method (53.8%, P = 0.046). The variance was lower (11.5) by the Bayesian estimation than by a conventional method (50.5, P = 0.003).
Results date posted
| 2019 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty sepsis patients with continuous blood purification therapy in the intensive care unit.
Participant flow
Registered sepsis patients administered vancomycin during continuous blood purification therapy in retrospective manner.
Adverse events
No adverse reactions was admitted.
Outcome measures
Compliance rate in therapeutic trough range (10-20 mg/L)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Five blood concentrations are sampled and measured in patients undergoing blood purification therapy around one dosing. Twenty patients are planed to be assembled for population pharmacokinetic analysis using NONMEM method. Subsequently, dose individualization is investigated.
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028012
