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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000044154 |
Receipt No. | R000050409 |
Scientific Title | A survey on the variation of medical costs according to the incidence level of perioperative delirium |
Date of disclosure of the study information | 2021/05/10 |
Last modified on | 2021/05/10 |
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 |
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Condition | ||
Condition | Delirium | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1) 20 years old or younger
2) Patients with a history of mental illness |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
y.koga@mw.kawasaki-m.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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). |
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Results date posted |
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Results Delayed |
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Results Delay Reason | Unregistered | ||||||
Date of the first journal publication of results |
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Baseline Characteristics | |||||||
Participant flow | |||||||
Adverse events | |||||||
Outcome measures | |||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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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 |
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Last modified on |
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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 |