UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035410
Receipt number R000040106
Scientific Title Ethanol lock therapy for catheter related blood stream infection
Date of disclosure of the study information 2019/01/01
Last modified on 2020/01/05 16:31:37

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Basic information

Public title

Ethanol lock therapy for catheter related blood stream infection

Acronym

Ethanol lock therapy

Scientific Title

Ethanol lock therapy for catheter related blood stream infection

Scientific Title:Acronym

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

1st name Yoshiaki
Middle name
Last name Kinoshita

Organization

Niigata University Dental and Medical Hospital

Division name

Pediatric Surgery

Zip code

9518510

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

1st name Yuhki
Middle name
Last name Arai

Organization

Niigata University Dental and Medical Hospital

Division name

Pediatric Surgery

Zip code

9518510

Address

Asahi-machi 1-754, Chuo-ku, Niigata, Japan

TEL

025-227-2258

Homepage URL


Email

arai@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University Dental and Medical Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Niigata University Dental and Medical Hospital

Address

Asahi-machi 1-754, Chuo-ku, Niigata, Japan

Tel

025-227-2258

Email

pedsurg@med.niigata-u.ac.jp


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


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

Open public recruiting

Date of protocol fixation

2018 Year 12 Month 30 Day

Date of IRB

2012 Year 01 Month 20 Day

Anticipated trial start date

2018 Year 12 Month 30 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 30 Day

Last modified on

2020 Year 01 Month 05 Day



Link to view the page

Value
https://center6.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