UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of ethanol lock therapy & antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous port
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kazuhiro Watanabe
Organization	Tohoku University Hospital
Division name	Gastrointestinal Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7205
Email	k-wata@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Kazuhiro Watanabe
Organization	Tohoku University Hospital
Division name	Gastrointestinal Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7205
Homepage URL
Email	k-wata@surg1.med.tohoku.ac.jp

Sponsor
Institute	Division of Gastrointestinal Surgery, Tohoku University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026494