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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name