UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031792 |
|---|---|
| Receipt number | R000036289 |
| Scientific Title | The correlation of plasma adrenomedullin level with the other parameters in the perioperative patients: a single-center prospective observational study |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2019/02/03 20:25:30 |
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Basic information
Public title
The correlation of plasma adrenomedullin level with the other parameters in the perioperative patients: a single-center prospective observational study
Acronym
The correlation of adrenomedullin level with the other perioperative parameters
Scientific Title
The correlation of plasma adrenomedullin level with the other parameters in the perioperative patients: a single-center prospective observational study
Scientific Title:Acronym
The correlation of adrenomedullin level with the other perioperative parameters
Region
| Japan |
Condition
Condition
surgery patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We measured the perioperative serial AM concentrations and examined the correlation between AM levels and some laboratory parameters or clinical parameters such as sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation (APACHE) II scores.
Basic objectives2
Others
Basic objectives -Others
Adrenomedullin as a perioperative biomakar
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma Adrenomedullin level
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Surgical patients aged over 20
Key exclusion criteria
Inadequate patients judged by responsible person
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Tsuneyoshi |
Organization
University of Miyazaki
Division name
Department of Anesthesiology
Zip code
Address
Miyazaki 889-1692, Japan
TEL
0985-85-9357
mmctm2@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoaki Maruta |
Organization
University of Miyazaki
Division name
Department of Anesthesiology
Zip code
Address
Miyazaki 889-1692, Japan
TEL
0985-85-9357
Homepage URL
mmctm2@yahoo.co.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
YES
Study ID_1
2014-096
Org. issuing International ID_1
University of Miyazaki
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
宮崎大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 19 | 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 | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We studied 123 patients undergoing nine kinds of surgeries. AM correlated highly with WBC, CRP, albumin, LDH, AST, PT, PCT, PSEP, IL-6, CAI, SOAF, and APACHE II (Spearman's rho = 0.51, 0.44, -0.46, 0.48, 0.47, 0.50, 0.46, 0.66, 0.59, 0.45, 0.72 and 0.60, respectively). SOFA was correlated most strongly with AM among the other parameters.
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036289
