UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019930 |
|---|---|
| Receipt number | R000022970 |
| Scientific Title | Evaluation of balanced hydroxyethylstarch(HES 130/0.4) in upper abdominal surgery monitoring using the transpulmonal themodilution method: A prospective randomized trial |
| Date of disclosure of the study information | 2015/11/26 |
| Last modified on | 2017/12/16 22:49:05 |
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Basic information
Public title
Evaluation of balanced hydroxyethylstarch(HES 130/0.4) in upper abdominal surgery monitoring using the transpulmonal themodilution method: A prospective randomized trial
Acronym
A prospective randomized trial of evaluation of balanced hydroxyethylstarch(HES 130/0.4) using the transpulmonal themodilution method
Scientific Title
Evaluation of balanced hydroxyethylstarch(HES 130/0.4) in upper abdominal surgery monitoring using the transpulmonal themodilution method: A prospective randomized trial
Scientific Title:Acronym
A prospective randomized trial of evaluation of balanced hydroxyethylstarch(HES 130/0.4) using the transpulmonal themodilution method
Region
| Japan |
Condition
Condition
hypovolemic state
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficasy of plasma substitute "Volven" in upper abdominal surgery is determined by using monitoring circulation parameter with EV1000.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Comparison of total fluid volume and extravascular lung water index in crystalloid solution or volven.
Key secondary outcomes
Whether or not the postoperative respiratory complication, and hospital stay.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Insertion of a catheter into a central vein and femoral artery.Connection EV1000 monitor to a patient(about 1 day)
Interventions/Control_2
Fluid resustation at hypovolemic state.
crystalloid solution(+) Volven(-)
Interventions/Control_3
Fluid resustation at hypovolemic state.
crystalloid solution(-) Volven(+)
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
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient that an upper abdominal surgery was planned
Key exclusion criteria
Patient of NYHA classification 3-4 degrees, Patient having a renal dysfunction or live dysfunction, postoperative Hb less than 9g/dl, something coagulopathy, operation history of respiratory organ, not cooperatively patient, other inappropriate patient.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noyuki Hirata |
Organization
Sapporo Medical University
Division name
Department of Anesthesiology
Zip code
Address
South 1, West 16 chuo-ku, Sapporo
TEL
011-611-2111
naohirata@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kazuma |
Organization
Sapporo medical university
Division name
Department of Anesthesiology
Zip code
Address
South 1, West 16 chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
sea_hawk_3104@yahoo.co.jp
Sponsor or person
Institute
Sapporo medical university, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Sapporo medical university, Department of Anesthesiology
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
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
札幌医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 26 | 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
| 2015 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2017 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022970
