UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012809 |
|---|---|
| Receipt number | R000014941 |
| Scientific Title | Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2015/08/12 19:02:32 |
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Basic information
Public title
Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study
Acronym
Circulatory dynamics optimizing study
Scientific Title
Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study
Scientific Title:Acronym
Circulatory dynamics optimizing study
Region
| Japan |
Condition
Condition
Esophageal cancer
Pancreatic cancer
Thoracoabdominal aortic aneurysm
Classification by specialty
| Hepato-biliary-pancreatic surgery | Vascular surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of intraoperative circulatory management using the parameters of a less invasive monitoring device (FloTrac/Vigileo system) on the patients short term outcomes and the reduction in intra-and postoperative medical care costs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Postoperative length of hospital stay
Key secondary outcomes
Intra-and postoperative medical expenses
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Bolus administration of 200ml of colloid when stroke volume variation is 13% or less
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients undergoing surgery due to esophageal cancer, pancreatic cancer, thoracoabdominal aortic aneurysm
2. Patinets of weight >40kg
3. Patients for whom arterial catheter is clinically needed for intraoperative continuous monitoring of arterial pressure.
4. Patients twenty years or older of age when undergoing the operation
Key exclusion criteria
1.Patients under twenty years of age
2.Patients with cardiac arrhythmia
3.Patients of Body Mass Inedex >40
4.Patients undergoing emergency surgeries
5.Patients who have not signed the informed concent
6.Patients undergoing repeat intervention due to postoperative hemorrhage
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Suzuki |
Organization
Tokai University School of Medicine
Division name
department of anesthesia
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193
TEL
0463-93-1211
suzuki3@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Ito |
Organization
Tokai University School of Medicine
Division name
department of anesthesia
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193
TEL
0463-93-1211
Homepage URL
itokenji@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine department of anesthesia
Institute
Department
Personal name
Funding Source
Organization
Edwards Lifesciences Limited
Organization
Division
Category of Funding Organization
Profit organization
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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 15 | 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
| 2013 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 10 | Day |
Last modified on
| 2015 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014941
