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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019930
Receipt No. 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

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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
Email 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
Email sea_hawk_3104@yahoo.co.jp

Sponsor
Institute Sapporo medical university, Department of Anesthesiology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022970

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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