UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Volume expanding effect and peripheral perfusion of 130 HES in the patients during perioperative period
Title of the study (Brief title)	Efficacy of 130 HES in the patients during perioperative period
Region	Japan

Condition
Condition	Perioperative patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will compare the effect of 130 HES in volume expansion, hemodynamic parameters and peripheral perfusion with that of 70 HES and bicarbonated Ringer solution.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Increase of circulation blood volume at 10 minutes after the administration of 130 HES, 70HES or bicarbonated Ringer solution.
Key secondary outcomes	Changes of blood pressure, heart rate, peripheral perfusion index and hemoglobin at 10 minutes after the administration of 130 HES, 70HES or bicarbonated Ringer solution.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of 500 ml of 130 HES in 10 minutes
Interventions/Control_2	Intravenous administration of 500 ml of 70 HES in 10 minutes
Interventions/Control_3	Intravenous administration of 500 ml of bicarbonated Ringer solution in 10 minutes
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with 1-2 of ASA physical status in elective surgery.
Key exclusion criteria	Patients with cardiovascular disease, hemorrhage and/or dehydration.
Target sample size	120

Research contact person
Name of lead principal investigator	Hiroaki Toyama
Organization	Tohoku University hospital
Division name	Department of Anesthesiology
Address	1-1 Seiryomachi, Aoba-ku, Sendai, Japan
TEL	022-717-7321
Email	h-toyama@umin.ac.jp

Public contact
Name of contact person	Hiroaki Toyama
Organization	Tohoku University Hospital
Division name	Department of Anesthesiology
Address	1-1 Seiryomachi, Aoba-ku, Sendai, Japan
TEL	022-717-7321
Homepage URL
Email	h-toyama@umin.ac.jp

Sponsor
Institute	Department of Anesthesiology, Tohoku University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Anesthesiology, Tohoku University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2016 Year 02 Month 28 Day
Date of closure to data entry	2016 Year 02 Month 28 Day
Date trial data considered complete	2016 Year 02 Month 28 Day
Date analysis concluded	2016 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 13 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022159