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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013417
Receipt No. R000015667
Scientific Title Comparison of 6% hydroxyethyl starch(130/0.4) with 5% albumin as intraoperative fluid during major abdominal surgery
Date of disclosure of the study information 2014/04/01
Last modified on 2016/03/19

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Basic information
Public title Comparison of 6% hydroxyethyl starch(130/0.4) with 5% albumin as intraoperative fluid during major abdominal surgery
Acronym Comparison of 6% hydroxyethyl starch(130/0.4) with 5% albumin as intraoperative fluid
Scientific Title Comparison of 6% hydroxyethyl starch(130/0.4) with 5% albumin as intraoperative fluid during major abdominal surgery
Scientific Title:Acronym Comparison of 6% hydroxyethyl starch(130/0.4) with 5% albumin as intraoperative fluid
Region
Japan

Condition
Condition carcinoma of liver, gallbladder, and pancreas
Classification by specialty
Hepato-biliary-pancreatic surgery Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare 6%HES130 to 5%albumin in major abdominal surgery with regard to postoperative kidney function, coagulation, and endothelial damage
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes postoperative kidney function and coagulation profile
Key secondary outcomes biochemical marker of endothelial damage

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 6% HES130 administration as intraoperative fluid
Interventions/Control_2 5% albumin administration as intraoperative fluid
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
80 years-old >
Gender Male and Female
Key inclusion criteria adult patients scheduled for major abdominal surgery
ASA physical status I, II
Key exclusion criteria preexisting kidney dysfunction, liver dysfunction, coagulopathy, anemia
current medication with steroid or diuretics
allergy to colloid solution
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaoru KOYAMA
Organization Saitama medical center
Division name anesthesiology
Zip code
Address 1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL 049-228-3654
Email tsuzuki@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinari SUZUKI
Organization Saitama medical center
Division name anesthesiology
Zip code
Address 1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL 049-228-3654
Homepage URL
Email tsuzuki@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 06 Month 30 Day
Date analysis concluded
2016 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2016 Year 03 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015667

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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