UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034202 |
|---|---|
| Receipt number | R000038961 |
| Scientific Title | Predictors Developing Atrial Fibrillation during Thoracic Surgery |
| Date of disclosure of the study information | 2018/09/20 |
| Last modified on | 2020/05/22 17:36:58 |
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Basic information
Public title
Predictors Developing Atrial Fibrillation during Thoracic Surgery
Acronym
Predictors Developing Atrial Fibrillation during Thoracic Surgery
Scientific Title
Predictors Developing Atrial Fibrillation during Thoracic Surgery
Scientific Title:Acronym
Predictors Developing Atrial Fibrillation during Thoracic Surgery
Region
| Japan |
Condition
Condition
Perioperative atrial fibrillation (AF)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether variations in pulse pressure after anesthetic induction are useful for predicting the development of AF during thoracoscopic esopahgectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was an intraoperative incidence of initial AF during the esophagectomy
Key secondary outcomes
Recurrent AF and major cardiovascular events within 30 postoperative days
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent scheduled thoracoscopic esophagectomy in our institute from April 2008 to March 2013
Key exclusion criteria
Patients with history of sustained or paroxysmal AF and with cardiac comorbidity as potential AF cases, including congestive heart failure, more than moderate grade of valvular heart diseases, supraventricular arrhythmias, and anti-arrhythmic medication
Patients who changed scheduled procedures during his or her operation
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokuhiro Yamada |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno, Osaka
TEL
+81-6-6645-2186
tk078@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokuhiro Yamada |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno, Osaka
TEL
+81-6-6645-2186
Homepage URL
tk078@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Address
Tel
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
| 2018 | Year | 09 | Month | 20 | 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
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationships between an intraoperative incidence of AF and the prognosis in 3 years of the postoperative period were additionally investigated.
Management information
Registered date
| 2018 | Year | 09 | Month | 19 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038961
