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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024314
Receipt No. R000028006
Scientific Title Changes of blood volume and physiological parameters after infusion of HES or crystalloid: a randomized-controlled study
Date of disclosure of the study information 2016/10/06
Last modified on 2019/04/09

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Basic information
Public title Changes of blood volume and physiological parameters after infusion of HES or crystalloid: a randomized-controlled study
Acronym Changes of blood volume after infusion of HES
Scientific Title Changes of blood volume and physiological parameters after infusion of HES or crystalloid: a randomized-controlled study
Scientific Title:Acronym Changes of blood volume after infusion of HES
Region
Japan

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

Objectives
Narrative objectives1 We will compare the effect of 130 HES in volume expansion, hemodynamic parameters, peripheral perfusion, and data of arterial blood gas analysis with that of 70 HES and bicarbonated Ringer solution.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Increases of blood volume and the blood pressure at 10 minutes after the completion of administration of 500 mL of 130 HES, 70HES or bicarbonate Ringer's solution.
Key secondary outcomes Changes of heart rate, peripheral perfusion index and oxygenation at 10 minutes after the acompletion of administration of 500 mL of 130 HES, 70HES or bicarbonate Ringer's solution.

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 Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous administration of 500 ml of 6% 130 HES in 20 minutes
Interventions/Control_2 Intravenous administration of 500 ml of 6% 70 HES in 20 minutes
Interventions/Control_3 Intravenous administration of 500 ml of bicarbonate Ringer's solution in 20 minutes
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

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, hemorrhage, dehydration, body weight (BW) < 35 kg or > 95 kg, cardiovascular disease, pulmonary disease, renal disease, diabetes mellitus, and/or mean arterial blood pressure < 40 mmHg at the baseline measurement.
Target sample size 100

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

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Toyama
Organization Tohoku University Hospital
Division name Department of Anesthesiology
Zip code
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

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
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 東北大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 06 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 10 Month 31 Day
Date of IRB
2016 Year 12 Month 05 Day
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
2017 Year 05 Month 25 Day
Date of closure to data entry
2017 Year 05 Month 25 Day
Date trial data considered complete
2017 Year 05 Month 25 Day
Date analysis concluded
2017 Year 06 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 06 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028006

Research Plan
Registered date File name
2017/05/18 【修正】研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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