UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022403 |
|---|---|
| Receipt number | R000025820 |
| Scientific Title | The effect of goal-directed therapy on the amount of blood loss during open hepatectomy:A prospective study |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2020/01/14 11:53:59 |
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Basic information
Public title
The effect of goal-directed therapy on the amount of blood loss during open hepatectomy:A prospective study
Acronym
The effect of goal-directed therapy during open hepatectomy
Scientific Title
The effect of goal-directed therapy on the amount of blood loss during open hepatectomy:A prospective study
Scientific Title:Acronym
The effect of goal-directed therapy during open hepatectomy
Region
| Japan |
Condition
Condition
liver diseases
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of goal-directed therapy using Flotrac sensor on the amount of blood loss during open hepatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The propotion of patients whose blood loss was less than 400ml
Key secondary outcomes
intraoperative total fluid balance
incidence of postoperative acute kidney injury
correlation between CVP and SVV at the beginning of GDT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
goal-directed therapy using predetermined protocol
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective open hepatectomy
Key exclusion criteria
partial hepatectomy
concomitant surgery for other organs
vascular resection and reconstruction
without central venous catherter
ASA PS is 3 or greater
arrhythmia
BMI is 35 or greater
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Morimoto |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Mizunoya |
Organization
Hokkaido University Hospital
Division name
Department of Anesthesiology
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
kazuyuki_mizunoya@hotmail.com
Sponsor or person
Institute
Department of Anesthesiology,Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
北海道大学病院（ほっかいどう）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 03 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025820
