UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019162 |
|---|---|
| Receipt number | R000018396 |
| Scientific Title | The examination about pharmacokinetics of Tazobactam/Piperacillin [2.25g*2times/day] in the patients who have the blood purification therapy |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2024/04/10 10:10:02 |
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Basic information
Public title
The examination about pharmacokinetics of Tazobactam/Piperacillin [2.25g*2times/day] in the patients who have the blood purification therapy
Acronym
The examination about pharmacokinetics of Tazobactam/Piperacillin [2.25g*2times/day] in the patients who have the blood purification therapy
Scientific Title
The examination about pharmacokinetics of Tazobactam/Piperacillin [2.25g*2times/day] in the patients who have the blood purification therapy
Scientific Title:Acronym
The examination about pharmacokinetics of Tazobactam/Piperacillin [2.25g*2times/day] in the patients who have the blood purification therapy
Region
| Japan |
Condition
Condition
The patients who have blood purification therapy in the intensive care unit and who need to take Tazobactam / Piperacillin [2.25g*2times/day]
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tazobactam / Piperacillin that is penicillins compound with beta-lctamase inhibitor has used widely around the world. Piperacillin is the standard antibiotics in chemotherapy. It is able to be used safely for the patients whose renal function are lower. Tazobactam is said that It also shows same pharmacokinetics. But we have few examples that shows scientifically. We examine the correct administration methodos of Tazobactam / Piperacillin in the Japanese patients who have continuous hemodiafilltration therapy in ICU after we measure drug level with time.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
We measure drug level in blood of patients and calculate parameters of population. We compare them with clinical datas and examine relevances blood concentration and expression of side effects.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who have continuous hemodiafilltration therapy in ICU and who need to take Tazobactam / Piperacillin
Key exclusion criteria
The patients who don't have continuous hemodiafilltration therapy
The patients who don't take Tazobactam / Piperacillin
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Nishi |
Organization
Hyogo college of medicine
Division name
ICU
Zip code
Address
1-1,Mukogawacho,Nishinomiya City,Hyogo,663-8501,Japan
TEL
+81-798-45-6389
hanakonakata0828@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hanako Kohama |
Organization
Hyogo college of medicine
Division name
I CU
Zip code
Address
1-1,Mukogawacho,Nishinomiya City,Hyogo,663-8501,Japan
TEL
+81-798-45-6389
Homepage URL
hanakonakata0828@hotmail.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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients who need to take Tazobactam/Piperacillin during carrying out continuous hemodiafiltration are selected to our study. Furthermore they enter our ICU from November 1st 2014 to October 31st 2015.
We measure plasma concentration and filtrate concentration of Tazobactam/Piperacillin.
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | 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=R000018396
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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