UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014409
Receipt number R000016763
Scientific Title Efeect of closed intravenous catheter system on preventing from catheter-related complication.
Date of disclosure of the study information 2014/09/01
Last modified on 2018/11/14 11:14:27

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Basic information

Public title

Efeect of closed intravenous catheter system on preventing from catheter-related complication.

Acronym

Closed intravenous catheter system and complication.

Scientific Title

Efeect of closed intravenous catheter system on preventing from catheter-related complication.

Scientific Title:Acronym

Closed intravenous catheter system and complication.

Region

Japan


Condition

Condition

critically ill patients

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effectiveness of closed intravenous cathetersystem on preventing from catheter related complication.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

peripheral intravenous catheter related complications: the rate of contamination of the top of the catheter, skin complication at the site of catheter insertion: redness, swelling, bleeding, ulcer.

Key secondary outcomes

obstruction or kink of catheter, phlebitis, intravenous infusion leakage


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

closed intravenous catheter systemer

Interventions/Control_2

peripheral intravenous cathet

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

18 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

critically ill patients who are expected to be admitted in ICU for more than 24 hours

Key exclusion criteria

1. Patients who is expected to be discharged from ICU within 24 hours.
2. Patients who do not need new peripheral infusion line.
3. Patients whose catheter is not able to be fixed appropriately such as burn patients.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Oto

Organization

The University of Tokushima Graduate School

Division name

Emergency and Critical Care Medicine

Zip code


Address

3-18-15 Kuramotocho Tokushima-city

TEL

088-633-9347

Email

joto@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Oto

Organization

The University of Tokushima Graduate School

Division name

Emergency and Critical Care Medicine

Zip code


Address

3-18-15 Kuramoto-cho Tokushima-city

TEL

088-633-9347

Homepage URL


Email

joto@tokushima-u.ac.jp


Sponsor or person

Institute

The University of Tokushima Graduate School

Institute

Department

Personal name



Funding Source

Organization

The University of Tokushima Graduate School

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

徳島大学病院(徳島県)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2014 Year 06 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 09 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

2014 Year 06 Month 28 Day

Last modified on

2018 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016763


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name