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

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 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


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

Value
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