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
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
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
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
