UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022982 |
|---|---|
| Receipt number | R000026494 |
| Scientific Title | Study of ethanol lock therapy & antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/07/01 22:46:46 |
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Basic information
Public title
Study of ethanol lock therapy & antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port
Acronym
Study of ethanol lock therapy & antimicrobial lock therapy
Scientific Title
Study of ethanol lock therapy & antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port
Scientific Title:Acronym
Study of ethanol lock therapy & antimicrobial lock therapy
Region
| Japan |
Condition
Condition
Case of catheter-related bloodstream infection in totally implantable central venous port
Classification by specialty
| Infectious disease | Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to assess the efficacy and safety of ethanol lock & antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the efficacy of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port.
Key secondary outcomes
To evaluate the safety of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
70% ethanol lock therapy (7 days)
Antimicribial lock therapy (7-14 days)
Systemic antimicrobial therapy (14-21 days)
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
Patients who underwent home parenteral nutrition by totally implantable central venous port.
2. fever more than 38.0 degree.
3. catheter-related bloodstream infection is suspected.
4. No severe complication by sepsis. General condition is good.
5. No allergy for antimicrobial drugs or ethanol which will be used in this study.
6. Silicine catheter was implanted
Key exclusion criteria
1.Patients with severe sepsis
2.Patients who underwent lock therapy for bacterial infection within 3 months
3.Patients who underwent lock therapy for fungal infection
4.Patients with pregnancy
5. Patients who doctors regarded as inadequate to participate this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
Tohoku University Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7205
k-wata@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
Tohoku University Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7205
Homepage URL
k-wata@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastrointestinal Surgery, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Gastrointestinal Surgery, Tohoku University Hospital
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
| 2016 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026494
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
