UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047874 |
|---|---|
| Receipt number | R000052191 |
| Scientific Title | Examination of the relationship between acute kidney injury and intraoperative infusion preparation in liver resection |
| Date of disclosure of the study information | 2022/05/27 |
| Last modified on | 2022/05/27 13:21:53 |
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Basic information
Public title
Examination of the relationship between acute kidney injury and intraoperative infusion preparation in liver resection
Acronym
Examination of the relationship between acute kidney injury and intraoperative infusion preparation in liver resection
Scientific Title
Examination of the relationship between acute kidney injury and intraoperative infusion preparation in liver resection
Scientific Title:Acronym
Examination of the relationship between acute kidney injury and intraoperative infusion preparation in liver resection
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In liver surgery, limiting the amount of intraoperative fluid can reduce central venous pressure and reduce bleeding from the cut surface of the liver. By using HES, it is possible to maintain oncotic pressure while limiting the amount of infusion, and it is expected that bleeding will be suppressed. On the other hand, HES has been pointed out to cause AKI in septic patients, but the incidence of postoperative AKI when used in scheduled surgery patients is not clear. HES will be used in liver surgery, which has a relatively high incidence of postoperative AKI of about 20%, and the incidence of AKI will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute kidney injury
Postoperative complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intraoperative infusion management is performed with Ringer's bicarbonate solution alone. Blood transfusion should be done at Hb 8.0g / dL or less or Ht 25% or less
Interventions/Control_2
Intraoperative fluid management is performed with HES alone. Blood transfusion should be done at Hb 8.0g / dL or less or Ht 25% or less
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo liver resection surgery during hospitalization at our hospital.
The age at the time of registration is 20 years or older.
Written consent has been obtained from the research subjects themselves for participation in the research.
Key exclusion criteria
Patients who are contraindicated for administration of HES preparation.
Research subjects who are judged by the principal investigator or the doctor in charge to be inappropriate for conducting this study safely.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kusaka |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki City, Osaka Prefecture
TEL
072-683-1221
yuusuke.kusaka@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamazaki |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki City, Osaka Prefecture
TEL
072-683-1221
Homepage URL
hiroyuki.yamazaki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University Hospital
Address
Osaka Medical and Pharmaceutical University Hospital
Tel
072-683-1221
rinri@ompu.ac.jp
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
| 2022 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052191
