UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efeect of closed intravenous catheter system on preventing from catheter-related complication.
Title of the study (Brief title)	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	Jun Oto
Organization	The University of Tokushima Graduate School
Division name	Emergency and Critical Care Medicine
Address	3-18-15 Kuramotocho Tokushima-city
TEL	088-633-9347
Email	joto@tokushima-u.ac.jp

Public contact
Name of contact person	Jun Oto
Organization	The University of Tokushima Graduate School
Division name	Emergency and Critical Care Medicine
Address	3-18-15 Kuramoto-cho Tokushima-city
TEL	088-633-9347
Homepage URL
Email	joto@tokushima-u.ac.jp

Sponsor
Institute	The University of Tokushima Graduate School
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016763