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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026401
Receipt No. R000030333
Scientific Title Atrial Fibrillation Treatment Evaluation Registry in the ICU
Date of disclosure of the study information 2017/03/31
Last modified on 2018/09/07

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Basic information
Public title Atrial Fibrillation Treatment Evaluation Registry in the ICU
Acronym AFTER-ICU study
Scientific Title Atrial Fibrillation Treatment Evaluation Registry in the ICU
Scientific Title:Acronym AFTER-ICU study
Region
Japan

Condition
Condition new-onset atrial fibrillation in critically ill patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of the persistence of new-onset AF in critically ill patients on outcome and examine the interventions for new-onset AF in Japan
Basic objectives2 Others
Basic objectives -Others To establish the registry for new-onset AF in critically ill patients
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Hospital mortality
2. Incidence of in-hospital stroke
Key secondary outcomes 1. ICU mortality
2. Hopital length of stay
3. ICU length of stay
4. AF persistent time

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. New-onset AF patients in the ICU
2. Aged 18 years or older
Key exclusion criteria 1. Patients with a prior history of AF
2. Patients who stayed shorter than
24 hours
in the ICU
3. ICU addmission for cardiac surgery
4. Patients with a pacemaker
5. Patients with a limitation of medical
therapy at the AF onset
6. Patients who declined participation
Target sample size 425

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuo Yoshida
Organization Jikei University School of Medicine
Division name Intensive Care Unit, Department of Anesthesiology
Zip code
Address 3-19-18, Nishi-Shinbashi Minato-ku
TEL +81-3-3433-1111
Email aftericustudy@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takuo Yoshida
Organization Jikei University School of Medicine
Division name Intensive Care Unit, Department of Anesthesiology
Zip code
Address 3-19-18, Nishi-Shinbashi Minato-ku
TEL +81-3-3433-1111
Homepage URL
Email aftericustudy@gmail.com

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization None
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational study

Management information
Registered date
2017 Year 03 Month 05 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030333

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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