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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013748
Receipt No. R000016045
Scientific Title Soluble CD14 subtype (presepsin) levels in the scheduled high-risk surgery patients who candidates ICU admission ; a prospective observational study
Date of disclosure of the study information 2014/04/21
Last modified on 2014/07/17

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Basic information
Public title Soluble CD14 subtype (presepsin) levels in the scheduled high-risk surgery patients who candidates ICU admission ; a prospective observational study
Acronym Soluble CD14 subtype (presepsin) levels in the scheduled high-risk surgery patients
Scientific Title Soluble CD14 subtype (presepsin) levels in the scheduled high-risk surgery patients who candidates ICU admission ; a prospective observational study
Scientific Title:Acronym Soluble CD14 subtype (presepsin) levels in the scheduled high-risk surgery patients
Region
Japan

Condition
Condition the scheduled high-risk surgery patients
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify that the level of presepsin in candidates for admission to ICU could not be changed by the high-risk operation.
Basic objectives2 Others
Basic objectives -Others Levels of presepsin, newly biomarker of the bacterial infection, could not be increased in high-risk surgical patients who candidates ICU admission.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To verify that the level of presepsin and procalcitonin (PCT) in candidates for admission to ICU could not be changed by the high-risk operation.
Key secondary outcomes (1) Evaluation of presepsin and PCT levels differ depending on operative procedure (Operative methods or cardiopulmonary bypass surgery).
(2) Evaluation of presepsin and PCT levels according to severity of the disease in ICU patients.
(3) Study of an influencing factor of level of presepsin and PCT.
(4) Relationship between survival rate (at Day 28, 60, 90) and levels of presepsin and PCT.
(5) The time course of changes in presepsin and PCT levels.

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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria The scheduled high-risk surgery patients who candidates ICU admission
Key exclusion criteria (1)Predict infectious disease before surgery.
(2)Emergency surgical patients.
(3)Patients who are judged as inappropriate candidates for the trial by the investigators on preoperative anesthetic consultation.
(4)Patients who are exposed to infection factor during the operation.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Nishida
Organization Fujita Health University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-9008
Email nishida@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Hara
Organization Fujita Health University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-9008
Homepage URL
Email harahara19801201@yahoo.co.jp

Sponsor
Institute Fujita Health University School of Medicine Department of Anesthesiology and Critical Care Medicine
Institute
Department

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
Email

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
2014 Year 04 Month 21 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
2014 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 21 Day
Last follow-up date
2014 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information During analysis

Management information
Registered date
2014 Year 04 Month 17 Day
Last modified on
2014 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016045

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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