UMIN-CTR Clinical Trial

Basic information
Public title	A survey on the variation of medical costs according to the incidence level of perioperative delirium
Acronym	A survey on the variation of medical costs according to the incidence level of perioperative delirium
Scientific Title	A survey on the variation of medical costs according to the incidence level of perioperative delirium
Scientific Title:Acronym	A survey on the variation of medical costs according to the incidence level of perioperative delirium
Region	Japan

Condition
Condition	Delirium
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to determine the extent to which medical costs (hospitalization costs and medical resource inputs) increase or decrease with the onset and severity of delirium in Japanese ICUs.
Basic objectives2	Others
Basic objectives -Others	Medical economic impact
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Medical costs
Key secondary outcomes	Length of hospitalization

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients admitted on or after April 1, 2016 and discharged by March 31, 2018.2)Kawasaki Medical School Hospital: Patients admitted to ICU after cardiovascular surgery. 3)Kawasaki Medical School General Medical Center: Patients admitted to the ICU after esophageal cancer surgery
Key exclusion criteria	1) 20 years old or younger 2) Patients with a history of mental illness
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Koga
Organization	Kawasaki University of Medical Welfare
Division name	Department of Nursing Faculty of Health and Welfare
Zip code	701-0193
Address	288,Matsushima,Kurashiki,Okayama, Japan
TEL	086-462-1111
Email	y.koga@mw.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Koga
Organization	Kawasaki University of Medical Welfare
Division name	Department of Nursing Faculty of Health and Welfare
Zip code	701-0193
Address	288,Matsushima,Kurashiki,Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	y.koga@mw.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki University of Medical Welfare
Institute
Department

Funding Source
Organization	Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawasaki University of Medical Welfare
Address	288,Matsushima,Kurashiki,Okayama, Japan
Tel	086-462-1111
Email	kenkyu@mw.kawasaki-m.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	3147
Org. issuing International ID_1	Kawasaki Medical School
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	川崎医科大学附属病院（岡山県）、川崎医科大学総合医療センター（岡山県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 10 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	122
Results	2 hospitals122 participants Age 72.50years(Median) Cardiovascular surgery:86.9% male patients:65.6% Non delirium(NDg):26.2% Subsyndromal delirium (SDg):43.4% Delirium(Dg):30.4% Medical costs(Median) NDg:34648.30USD SDg:45596.54USD Dg:53546.04USD There was a significant difference in the comparison between all groups(p<0.01), Length of hospitalization(Median) NDg 22days,SDg 27days,Dg 31days.NDg was significantly different from Dg(p<0.01).
Results date posted	2021 Year 05 Month 08 Day
Results Delayed	Delay expected
Results Delay Reason	Unregistered
Date of the first journal publication of results	2021 Year 05 Month 08 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 22 Day
Date of IRB	2018 Year 08 Month 03 Day
Anticipated trial start date	2018 Year 08 Month 04 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2021 Year 05 Month 08 Day
Date trial data considered complete	2021 Year 05 Month 08 Day
Date analysis concluded	2021 Year 05 Month 08 Day

Other

Other related information

We will list patients who meet the conditions described in the "Patients to be surveyed" section at the medical affairs section of the hospital, and obtain information on the patient's basic background, D file, EF integration file, H file, and total hospitalization cost from the medical record number and DPC data. Then, information on the onset of delirium during ICU stay and the duration of ICU stay are collected from the electronic medical record using the medical record number.

Management information
Registered date	2021 Year 05 Month 10 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050409

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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