UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024314 |
|---|---|
| Receipt number | 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 19:15:38 |
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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
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
h-toyama@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028006
