UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029471 |
|---|---|
| Receipt number | 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 00:03:32 |
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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
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
noriaki.0909@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033673
