UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022380
Receipt number R000025791
Scientific Title The effects of 6% hydroxyethyl starch on ischemia-reperfusion injury in total knee replacement surgery with tourniquet application
Date of disclosure of the study information 2016/05/20
Last modified on 2016/05/24 13:54:50

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Basic information

Public title

The effects of 6% hydroxyethyl starch on ischemia-reperfusion injury in total knee replacement surgery with tourniquet application

Acronym

Can 6% hydroxyethyl starch solution reduce ischemic reperfusion injury from pneumatic tourniqutte application

Scientific Title

The effects of 6% hydroxyethyl starch on ischemia-reperfusion injury in total knee replacement surgery with tourniquet application

Scientific Title:Acronym

Can 6% hydroxyethyl starch solution reduce ischemic reperfusion injury from pneumatic tourniqutte application

Region

Asia(except Japan)


Condition

Condition

6% hydroxyethyl starch, tourniqutte application, total knee arthroplasty, ischemic-reperfusion syndrome

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In patients receiving total knee arthroplasty using tourniqutte, we hypothesize that preoperative infusion of 6% hydroxyethyl starch solution can reduce ischemic reperfusion synfrome.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Difference of serum malondialdehide level before and after tourniqutte application in each group, 6% hydroxyethyl starch group and normal saline group.

Key secondary outcomes

Differences of serum malondialdehide between the groups, 6%hydroxyethyl starch and normal saline group before and after tourniqutte application.
Differences of serum total protein, albumin level between two groups before and after tourniqutte application.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Before combined spinal anesthesia, the patients allocated in group HES, received intravenously 6% hydroxyethyl starch solution 10ml/kg(body weight).

Interventions/Control_2

Before combined spinal epidural anesthesia, the patients allocated in group NS, received intravenously normal saline 10ml/kg(body weight).

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

65 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

scheduled total knee arthroplaty
unilateral
under combined epidural-spinal anesthesia

Key exclusion criteria

emergency surgery
uncontrolled hypertension, diabetes
ASA class III, IV

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name JAE HO LEE

Organization

National Health Institution Ilsan Hospital

Division name

Department of Anesthesiology and Pain Medicine

Zip code


Address

1232, Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea

TEL

82319000298

Email

lijhmd71@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name JAE HO LEE

Organization

National Health Institution Ilsan Hospital

Division name

Department of Anesthesiology and Pain Medicine

Zip code


Address

1232, Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea

TEL

82319000298

Homepage URL


Email

lijhmd71@hotmail.com


Sponsor or person

Institute

National Health Insurance Corporation Ilsan Hospital

Institute

Department

Personal name



Funding Source

Organization

National Health Insurance Corporation Ilsan Hospital

Organization

Division

Category of Funding Organization

Outside Japan

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

2016 Year 05 Month 20 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

Enrolling by invitation

Date of protocol fixation

2016 Year 05 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 20 Day

Last modified on

2016 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025791


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name