UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028019
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yasudahideto@me.com

Sponsor
Institute Department of Intensive Care Medicine, Kameda medical Center
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.