UMIN-CTR Clinical Trial

Basic information
Public title	Levetiracetam pharmacokinetics analysis and elucidation of appropriate administration design in critically ill patients
Acronym	Levetiracetam pharmacokinetics analysis and elucidation of appropriate administration design in critically ill patients
Scientific Title	Levetiracetam pharmacokinetics analysis and elucidation of appropriate administration design in critically ill patients
Scientific Title:Acronym	Levetiracetam pharmacokinetics analysis and elucidation of appropriate administration design in critically ill patients
Region	Japan

Condition
Condition	Severely ill patients requiring administration of antiepileptics drugs
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pharmacokinetics of levetiracetam by renal function and CRRT in critically ill patients ,elucidation of changes and establishment of appropriate administration design
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of Levetiracetam pharmacokinetics by renal function
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Immediately before the end of the infusion on the day when levetiracetam is administered, and 0.5,1,2,4,8and12 hours after the end of the infusion,a total of 7 blood samples and dialysis filtrate are collected. A single blood sampling volume of about 3ml is required.
Interventions/Control_2	Immediately before the end of the infusion on the day when levetiracetam is administered, and 0.5,1,2,4,8and12 hours after the end of the infusion,a total of 7 blood samples are collected. A single blood sampling volume of about 3ml is required.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Inpatients receiving levetiracetam in the ICU 2)Patients over 20 years old 3)Patients whose consent has been obtained in writing by the person or his / her substitute
Key exclusion criteria	1) When an adverse event occurs 2)When the underlying disease worsens and the doctor in charge decides that it should be the center 3)A serious violation of the research implementation plan was found. 4)The subject canceled the research participation. 5)The subject's cooperation could not be obtained.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Nishi
Organization	Hyogo College of Medicine
Division name	Intensive Care Unit
Zip code	663-8501
Address	1-1,Mukogawa-cho,Nishinomiya-city,Hyogo,Japan
TEL	0798-45-6389
Email	shinitch@gmail.com

Public contact
Name of contact person	1st name mana Middle name Last name taguchi
Organization	Hyogo College of Medicine
Division name	Intensive Care Unit
Zip code	663-8501
Address	1-1,Mukogawa-cho,Nishinomiya-city,Hyogo,Japan
TEL	0798-45-6389
Homepage URL
Email	bbbsc333mana@gmail.com

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo College of Medicine
Address	1-1,Mukogawa-cho,Nishinomiya-city,Hyogo,Japan
Tel	0798-45-6389
Email	rinri@hyo-med.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	2021 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 01 Month 31 Day
Date of IRB	2021 Year 08 Month 01 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 28 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049262