UMIN-CTR Clinical Trial

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
Email	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
Email	kazutakaoda-kuh@umin.ac.jp

Sponsor
Institute	Kumamoto University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028012