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

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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

Email

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/

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name