UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043692 |
|---|---|
| Receipt number | R000049889 |
| Scientific Title | Landiolol for Prevention of Atrial Fibrillation after Proximal Aortic Surgery |
| Date of disclosure of the study information | 2021/03/22 |
| Last modified on | 2021/03/22 08:36:57 |
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Basic information
Public title
The efficacy of Landiolol Administration for Prevention of Atrial Fibrillation after Proximal Aortic Surgery
Acronym
Landiolol administration for POAF
Scientific Title
Landiolol for Prevention of Atrial Fibrillation after Proximal Aortic Surgery
Scientific Title:Acronym
Landiolol for POAF after proximal aortic surgery
Region
| Japan |
Condition
Condition
the aneurysm of aortic root, ascending aorta, or aortic arch/the dissection of proximal aorta
Classification by specialty
| Cardiology | Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
reduction of the incidence of new-onset postoperative atrial fibrillation (POAF)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduction of the incidence of new-onset POAF that occurred within 72 hrs after operation
Key secondary outcomes
30-day mortality, 30-day symptomatic cerebral infarction, length of hospital stay (days), length of ICU stay (days), length of mechanical ventilation (hours), need for pacemaker support (using pacemaker for stability of hemodynamics), and average of mean BP and HR during 72 hrs after ICU admission
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients more than 18 years old without preoperative AF who underwent proximal aortic surgery at Hiroshima City Hospital between January 1, 2011, and December 31, 2018
Key exclusion criteria
preoperative AF
CABG or valve surgery performed with aortic surgery
missing data
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | jun |
| Middle name | |
| Last name | kaminohara |
Organization
Kokura memorial hospital
Division name
Department of anesthesiology
Zip code
8028555
Address
3-2-1, Asano, Kitakyushu Kokurakita-ku, Fukuoka
TEL
093-511-2000
stujunjun1031@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Takatori |
Organization
Hiroshima City Hospital
Division name
Department of Anesthesia and Intensive care
Zip code
7308518
Address
7-33, Motomachi, Hiroshima Naka Ku, Hiroshima
TEL
082-221-2291
Homepage URL
takatori@ksj.biglobe.ne.jp
Sponsor or person
Institute
Hiroshima city hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Hiroshima City Hospital
Address
Department of Anesthesia and Intensive care
Tel
082-221-2291
stujunjun1031@yahoo.co.jp
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
広島市立広島市民病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.city-hosp.naka.hiroshima.jp/guide/info/activity_2.php
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
264
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
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively collected pre- and peri-operative patients' data shown in Tables from the patient records.
Management information
Registered date
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049889
