UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013417 |
|---|---|
| Receipt number | 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 17:28:44 |
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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
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
tsuzuki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015667
