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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031792
Receipt No. 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

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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
Email 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
Email mmctm2@yahoo.co.jp

Sponsor
Institute University of Miyazaki
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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