UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013748 |
|---|---|
| Receipt number | 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 18:35:39 |
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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
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
harahara19801201@yahoo.co.jp
Sponsor or person
Institute
Fujita Health University School of Medicine Department of Anesthesiology and Critical Care Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016045
