UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043164
Receipt number R000049262
Scientific Title Levetiracetam pharmacokinetics analysis and elucidation of appropriate administration design in critically ill patients
Date of disclosure of the study information 2021/01/29
Last modified on 2021/01/28 13:52:37

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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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049262


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name