UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035410
Receipt No. R000040106
Official scientific title of the study Ethanol lock therapy for catheter related blood stream infection
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Ethanol lock therapy for catheter related blood stream infection
Title of the study (Brief title) Ethanol lock therapy
Region
Japan

Condition
Condition catheter related blood stream infection
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have to keep CV catheter and access vascular in children who need parenteral nutrition for a long time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We check blood test and blood culture 3 days, 5 days and 7 days after the therapy.
Key secondary outcomes

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 Lock the catheter by ethanol for 4 hours
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
1 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Intestinal failure who need parenteral nutrision for a long time
Key exclusion criteria Patients who don't need parenteral nutrition
Target sample size 10

Research contact person
Name of lead principal investigator Kubota Masayuki
Organization Niigata University Dental and Medical Hospital
Division name Pediatric Surgery
Address Asahi-machi 1-754, Chuo-ku, Niigata, Japan
TEL 025-227-2258
Email kubotama@med.niigata-u.ac.jp

Public contact
Name of contact person Arai Yuhki
Organization Niigata University Dental and Medical Hospital
Division name Pediatric Surgery
Address Asahi-machi 1-754, Chuo-ku, Niigata, Japan
TEL 025-227-2258
Homepage URL
Email arai@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Dental and Medical Hospital
Institute
Department

Funding Source
Organization Niigata University Dental and Medical 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
2019 Year 01 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 12 Month 30 Day
Anticipated trial start date
2018 Year 12 Month 30 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
2018 Year 12 Month 30 Day
Last modified on
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.