UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002023 |
|---|---|
| Receipt number | R000002469 |
| Scientific Title | The change for blood level of antibacterial agent in blood purification therapy for sepsis. |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2009/06/01 05:48:23 |
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Basic information
Public title
The change for blood level of antibacterial agent in blood purification therapy for sepsis.
Acronym
The change for blood level of antibacterial agent in blood purification therapy for sepsis.
Scientific Title
The change for blood level of antibacterial agent in blood purification therapy for sepsis.
Scientific Title:Acronym
The change for blood level of antibacterial agent in blood purification therapy for sepsis.
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation for dose of antibacterial agent in blood purification therapy for sepsis.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation for blood level of antibacterial agent in blood purification therapy for sepsis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)sepsis
2)acute or chronic renal failure
3)blood purification therapy
4)antibacterial therapy
patient fulfilles 1), 2), 3)and 4).
Key exclusion criteria
none.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Hara |
Organization
Kainan Hospital
Division name
Department of Emergency, Critical Care Medicine and Anesthesiology
Zip code
Address
396 Minami honden, Maegasu-cho, Yatomi-city, Aichi, Japan
TEL
0567-65-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Hara |
Organization
Kainan Hospital
Division name
Department of Emergency, Critical Care Medicine and Anesthesiology
Zip code
Address
396 Minami honden, Maegasu-cho, Yatomi-city, Aichi, Japan
TEL
0567-65-2511
Homepage URL
harahara19801201@yahoo.co.jp
Sponsor or person
Institute
Kainan Hospital
Institute
Department
Personal name
Funding Source
Organization
Kainan Hospital
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
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
| 2009 | Year | 06 | Month | 01 | 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
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
First, we will evaluate about meropenem or linezolid.
Management information
Registered date
| 2009 | Year | 06 | Month | 01 | Day |
Last modified on
| 2009 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002469
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
