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 UMIN000029471
Receipt No. R000033673
Scientific Title The ability to monitor fluid responsiveness using the estimated Continuous Cardiac Output
Date of disclosure of the study information 2017/10/08
Last modified on 2019/10/16

* 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 The ability to monitor fluid responsiveness using the estimated Continuous Cardiac Output
Acronym The ability to monitor fluid responsiveness using the estimated Continuous Cardiac Output
Scientific Title The ability to monitor fluid responsiveness using the estimated Continuous Cardiac Output
Scientific Title:Acronym The ability to monitor fluid responsiveness using the estimated Continuous Cardiac Output
Region
Japan

Condition
Condition open abdominal surgery
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy and the accuracy of monitor fluid responsiveness using esCCO
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the chronological correlation between esCCO and FloTrac monitoring regarding coadiac output and stroke vovume variation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 cardiac output monitoring by ECG and pulse oxymetry
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria open abdominal surgery
Key exclusion criteria patients less than 20 years old
low cardiac function
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ryoichi
Middle name
Last name Ochiai
Organization Omori Hospital, School of Medicine, Faculty of Medicine, Toho University.
Division name Department of Anesthesiology
Zip code 1438541
Address 6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Email ochiai-r@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Noriaki
Middle name
Last name Sakamoto
Organization Omori Hospital, School of Medicine, Faculty of Medicine, Toho University.
Division name Department of Anesthesiology
Zip code 1438541
Address 6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email noriaki.0909@med.toho-u.ac.jp

Sponsor
Institute Toho University.
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Omori Hospital, School of Medicine, Faculty of Medicine, Toho University.
Address 6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
Tel 03-3762-4151
Email noriaki.0909@med.toho-u.ac.jp

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 10 Month 08 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 46
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 10 Month 01 Day
Date of IRB
2018 Year 09 Month 19 Day
Anticipated trial start date
2018 Year 10 Month 08 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 08 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.