UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007561 |
|---|---|
| Receipt number | R000006764 |
| Scientific Title | Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2022/10/02 18:36:53 |
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Basic information
Public title
Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Acronym
Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Scientific Title
Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Scientific Title:Acronym
Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Does Landiolol Hydrochloride decrease the incidence of atrial fiblillation after lung resection?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the frequency of atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous prasebo, Glucose 5% during operation.
Interventions/Control_2
Intravenous landiolol hydrochloride during the operation.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who have lung cancer, to be treated by pnemonectomy or bilbectomy.
Key exclusion criteria
(1) patients without previous or current cardiovascular history
(2) bradycardia
(3) superventricular arrhythmia
(4) significant alteration of atrioventricular conduction
Patients with sick sinus syndromr
Patients with chronic inflammatory disease
Patients with moderate - severe valvular disease
Patients with significant liver failure
Patients with significant renal failure
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Sakamoto |
Organization
Nippon Medical School
Division name
Department of Anesthesiology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL
0338222131
fuku-kaori@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yagi |
| Middle name | |
| Last name | Kaori |
Organization
Nippon Medical School
Division name
Department of Anesthesiolgy
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL
0338222131
Homepage URL
fuku-kaori@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Department of Anesthesiolgy
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Department of Anesthesiolgy
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
Nippon Medical School
Address
1-1-5, Sendagi Bunkyou-ku
Tel
03-3822-2131
clinicaltrial@nms.ac.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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006764
