UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041150 |
|---|---|
| Receipt number | R000046996 |
| Scientific Title | Quantitative analysis of the surgery-induced inflammatory response on the body fluid distribution. |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2023/07/24 15:49:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observation of the effects of inflammatory response caused by surgery on the body fluid
Acronym
Inflammatory response and body fluid
Scientific Title
Quantitative analysis of the surgery-induced inflammatory response on the body fluid distribution.
Scientific Title:Acronym
Inflammatory response and body fluid
Region
| Japan |
Condition
Condition
Major abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quantitative evaluation of insensitive fluid loss and fluid shift caused by inflammatory response during general anesthesia in patients undergoing major surgery
Basic objectives2
Others
Basic objectives -Others
Determination of pathophysiological process
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
)Correlation analysis between plasma presepsin, syndecan-1 and body composition during surgery and first postoperative day
Key secondary outcomes
(1)Correlation analysis between plasma presepsin, syndecan-1 and body weight change during surgery and first postoperative day
(2) Correlation analysis between plasma presepsin, syndecan-1 and urinary NGAL-1 concentration during surgery and first postoperative day
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective major non-cardiac surgery
Estimated surgical duration over 6 hours
Postoperative ICU admission
Key exclusion criteria
Preoperative systemic inflammation
Preoperative chronic kidney disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawamura |
Organization
Toho University Ohashi Medical Center
Division name
Institutional review board
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ohashi.rinri@ext.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Toho University Ohashi Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional review board, Toho University Ohashi Medical Center
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
Tel
03-3468-1251
ohashi.rinri@ext.toho-u.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
東邦大学医療センター大橋病院（東京都）
Toho University Ohashi Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
(1)Body weight and body composition measurement before, after general anesthesia and 1st postoperative day in the intensive care unit.
(2)plasma presepsin, syndecan-1 concentration and urine NGAL-1 concentration determination
(3)Correlation analysis between plasma presepsin, syndecan-1 and body weight change
(4)Correlation analysis between plasma presepsin, syndecan-1 and body composition
(5) Correlation analysis between plasma presepsin, syndecan-1 and urinary NGAL-1 concentration
Management information
Registered date
| 2020 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046996
