UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007561
Receipt No. 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 2017/09/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Atsuhiro Sakamoto
Organization Nippon Medical School
Division name Department of Anesthesiology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL 0338222131
Email fuku-kaori@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Yagi
Organization Nippon Medical School
Division name Department of Anesthesiolgy
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL 0338222131
Homepage URL
Email fuku-kaori@nms.ac.jp

Sponsor
Institute Nippon Medical School
Department of Anesthesiolgy
Institute
Department

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
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
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
2017 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006764

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.