UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021881
Receipt number R000025230
Scientific Title The effects of hydroxyethyl starch loading on perioperative fluid balance
Date of disclosure of the study information 2016/04/12
Last modified on 2018/02/13 21:58:41

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Basic information

Public title

The effects of hydroxyethyl starch loading on perioperative fluid balance

Acronym

The effects of hydroxyethyl starch loading on perioperative fluid balance

Scientific Title

The effects of hydroxyethyl starch loading on perioperative fluid balance

Scientific Title:Acronym

The effects of hydroxyethyl starch loading on perioperative fluid balance

Region

Japan


Condition

Condition

Relative hypovolemia on anesthesia induction

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to study the effects of hydroxyehyl starch loading for relative hypovolemia caused by anesthesia induction on perioperative fluid balance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Perioperative fluid balance (infusion, transfusion, urine output, blood loss).

Key secondary outcomes

Dose of vasopressors.
Count of blood cells (WBC, RBC, Hb, Platelets), Biochemical test (Alb, AST, ALT, LDH, BUN,Cr, CRP, electrolytes) on 0, 1 and 7 postoperative day.
Postoperative ICU stay days
Postoperative in-hospital days


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hydroxyethyl starch loading

Interventions/Control_2

Acetate Ringer's solution loading

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases scheduled for elective laparoscopic gastrointestinal malignancy surgery and postoperative ICU admission

Key exclusion criteria

History of hydroxyethyl starch allergy, congestive heart failure, renal insufficiency, coagulation abnormality or thrombocytopenia.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromi Katoh

Organization

Hyogo Cancer Center

Division name

Department of Anesthesia

Zip code


Address

13-70 Kitaoji Akashi

TEL

0789291151

Email

whoami@hp.pref.hyogo.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromi Katoh

Organization

Hyogo Cancer Center

Division name

Department of Anesthesia

Zip code


Address

13-70 Kitaoji Akashi

TEL

0789291151

Homepage URL


Email

whoami@hp.pref.hyogo.jp


Sponsor or person

Institute

Department of Anesthesia
Hyogo Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Deartment of Anesthesia
Hyogo Cancer Center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


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

兵庫県立がんセンター(兵庫県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 12 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

2016 Year 04 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 13 Day

Last follow-up date

2018 Year 11 Month 22 Day

Date of closure to data entry

2018 Year 11 Month 30 Day

Date trial data considered complete

2018 Year 11 Month 30 Day

Date analysis concluded

2018 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 12 Day

Last modified on

2018 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025230


Research Plan
Registered date File name
2017/10/13 HES研究実施計画書_2.pages

Research case data specifications
Registered date File name

Research case data
Registered date File name