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

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 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


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

Value
https://center6.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