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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020238
Receipt No. R000023325
Scientific Title A study on the postoperative arrhythmia and cytokine concentration with landiolol infusion in patients undergoing esophageal cancer surgery
Date of disclosure of the study information 2015/12/17
Last modified on 2015/12/23

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Basic information
Public title A study on the postoperative arrhythmia and cytokine concentration with landiolol infusion in patients undergoing esophageal cancer surgery
Acronym Effect of perioperative landiolol infusion on the postoperative arrhythmia and cytokine concentrateon
Scientific Title A study on the postoperative arrhythmia and cytokine concentration with landiolol infusion in patients undergoing esophageal cancer surgery
Scientific Title:Acronym Effect of perioperative landiolol infusion on the postoperative arrhythmia and cytokine concentrateon
Region
Japan

Condition
Condition patients who were scheduled to undergo esophagectomy for esophageal cancer
Classification by specialty
Gastrointestinal surgery Anesthesiology Operative medicine
Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine whether perioperative landiolol administration suppresses postoperative atrial fibrillation and the plasma cytokines elevation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidences of tachycardia (100>bpm) or arterial fibrillation during 48 hours after surgery
Key secondary outcomes plasma concentrations of cytokines (IL-1beta, IL-6, IL-8, IL-10, TNF-alpha) after the induction of anesthesia, after the surgery, the 1st postoperative day (POD), and 2nd POD

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
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 Landiolol is infused continuously at 5 mcg/kg/min from before the surgery for 48 hours.
Interventions/Control_2 Saline is infused continuously from before surgery for 48 hours.
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1 or 2 patients who were scheduled to undergo esophagectomy for esophageal cancer at Akita University Hospital were enrolled.
Key exclusion criteria Patients with a history of cardiac (eg, atrial fibrillation, conduction abnormalities, arrhythmias, antiarrhythmic medication including beta-blockers, recent angina pectoris, myocardial infarction), pulmonary, or renal disease, thyroid dysfunction were excluded from the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Goyagi
Organization Akita University Graduate School of Medicine
Division name Anesthesiology and Intensive Care Medicine
Zip code
Address 1-1-1, Hondo, Akita-city, Akita
TEL 018-884-6175
Email tgoyagi@doc.med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Goyagi
Organization Akita University Graduate School of Medicine
Division name Anesthesiology and Intensive Care Medicine
Zip code
Address 1-1-1, Hondo, Akita-city, Akita
TEL 018-884-6175
Homepage URL
Email tgoyagi@doc.med.akita-u.ac.jp

Sponsor
Institute Akita University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology and Intensive Care Medicine, Akita University Graduate School of Medicine
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
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 秋田大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 17 Day
Last modified on
2015 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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