UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Incidence And risk factors of phlebitis and coMplicatiOns due to peRipheral VENoUS catheter in critically ill patients
Title of the study (Brief title)	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	Hideto Yasuda
Organization	Kameda medical Center
Division name	Department of Intensive Care Medicine
Address	929, Higashi-chou, Kamogawa-shi, Chiba, 296-8602, Japan
TEL	04-7092-2211
Email	yasudahideto@me.com

Public contact
Name of contact person	Hideto Yasuda
Organization	Kameda medical Center
Division name	Department of Intensive Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032063