UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The correlation of plasma adrenomedullin level with the other parameters in the perioperative patients: a single-center prospective observational study
Title of the study (Brief title)	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	Isao Tsuneyoshi
Organization	University of Miyazaki
Division name	Department of Anesthesiology
Address	Miyazaki 889-1692, Japan
TEL	0985-85-9357
Email	mmctm2@yahoo.co.jp

Public contact
Name of contact person	Toyoaki Maruta
Organization	University of Miyazaki
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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