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

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 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


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

Value
https://center6.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
Registered date File name