UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028019 |
|---|---|
| Receipt number | R000032063 |
| Scientific Title | Incidence And risk factors of phlebitis and coMplicatiOns due to peRipheral VENoUS catheter in critically ill patients |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/07/01 09:34:51 |
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Basic information
Public title
Incidence And risk factors of phlebitis and coMplicatiOns due to peRipheral VENoUS catheter in critically ill patients
Acronym
AMOR-VENUS study
Scientific Title
Incidence And risk factors of phlebitis and coMplicatiOns due to peRipheral VENoUS catheter in critically ill patients
Scientific Title:Acronym
AMOR-VENUS study
Region
| Japan |
Condition
Condition
Patients admitted to ICU with an intravenous catheter inserted
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Frequency of occurrence of phlebitis by peripheral venous catheter and investigation of its risk factor.
2. Investigation of the type and frequency of intravascular catheter inserted in ICU.
3. Evaluation of safety in intravenous catheter management and evaluation of usefulness of ICU full-time pharmacist
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and the risk factors of peripheral venous phlebitis with ICU patients
Key secondary outcomes
1. Occurrence of major complications in peripheral venous catheters.
2. Insertion status of various intravenous catheters in ICU (peripheral venous catheter, central venous catheter, peripheral inserted central venous catheter, dialysis catheter, pulmonary artery catheter, arterial pressure catheter).
3. Incidence of peripheral venous catheter related bloodstream infection.
4. Relevance of administration route of various drugs
5. Effectiveness of ICU full-time pharmacist
6. Concordance rate of phlebitis diagnosis
7. Occurrence of Post-infusion / insertion phlebitis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient admitted to ICU with an intravenous catheter inserted
Key exclusion criteria
1. under 18 years
2. In the cases showing research refusal
3. In the cases judging that the attending physician is unable to participate in the research
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideto Yasuda |
Organization
Kameda medical Center
Division name
Department of Intensive Care Medicine
Zip code
Address
929, Higashi-chou, Kamogawa-shi, Chiba, 296-8602, Japan
TEL
04-7092-2211
yasudahideto@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto Yasuda |
Organization
Kameda medical Center
Division name
Department of Intensive Care Medicine
Zip code
Address
929, Higashi-chou, Kamogawa-shi, Chiba, 296-8602, Japan
TEL
04-7092-2211
Homepage URL
yasudahideto@me.com
Sponsor or person
Institute
Department of Intensive Care Medicine, Kameda medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology-Japan
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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
Nothing in particular
Management information
Registered date
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2018 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032063
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
