UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020238 |
|---|---|
| Receipt number | 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 14:19:56 |
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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
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
tgoyagi@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023325
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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