UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015993 |
|---|---|
| Receipt number | R000018403 |
| Scientific Title | Effectiveness of Landiolol for elderly patients at high risk of a cardiovascular event who undergo laparoscopic gastrecomy which potentially induces low cardiac function and tachycardia |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2020/06/22 09:52:11 |
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Basic information
Public title
Effectiveness of Landiolol for elderly patients at high risk of a cardiovascular event who undergo laparoscopic gastrecomy which potentially induces low cardiac function and tachycardia
Acronym
Effectiveness of Landiolol in perioperative management of laparoscopic gastrectomy
Scientific Title
Effectiveness of Landiolol for elderly patients at high risk of a cardiovascular event who undergo laparoscopic gastrecomy which potentially induces low cardiac function and tachycardia
Scientific Title:Acronym
Effectiveness of Landiolol in perioperative management of laparoscopic gastrectomy
Region
| Japan |
Condition
Condition
General anesthesia, pneumoperitoneum under gastrectomy
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Anesthesiology |
| Cardiovascular surgery | Operative medicine | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The patients at high risk for cardiovascular events in older subjects, it is intended to examine the therapeutic and preventive effect of onset landiolol for supra ventricular tachycardia and postoperative complications in laparoscopic gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of supra ventricular arrhythmia in 72 hours from the start of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Landiolol groups: surgery to perform continuously administered intravenously at a safe administration rate 1mcg/kg/min obtained from the results of pilot study on the dose of landiolol. Postoperatively, the heart rate 60 times/min or more 80 times/min or less, to adjust the dose rate as a guide to be maintained in systolic blood pressure 90mmHg or more. The maximum dose rate at this time I will be with 10mcg/kg/min.
Interventions/Control_2
Control group(non-administration group): carrying out the usual treatment without administration of landiolol.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, It does not matter the gender at 65 years of age or elder.
2, Patients in the evaluation of using the two or more preoperative Revised Cardiac Risk Index(RCRI)
Key exclusion criteria
1. Patients contraindicated of landiolol. (Patients with cardiogenic shock, patients with diabetic acidosis, atrioventricular block II degrees or more), bradyarrhythmia patients such as sick sinus syndrome, patients with pulmonary hypertension and right heart failure, patients with congestive heart failure, patients with untreated pheochromocytoma, and patients with a history of hypersensitivity to landiolol)
2. Patients with emergency surgery
3. Patients with heart rate of 40 times/min or less
4. patients with low blood pressure (systolic blood pressure less than 80mmHg)
5. Patients with severe heart failure (NYHA classification III,IV)
6.Patients assessed by anesthetist preoperative patients participating in the study are determined to be unsuitable
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Uyama |
Organization
Fujita Health University
Division name
Division of Upper GI, Department of Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan
TEL
0562-93-9254
iuyama@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suda |
Organization
Fujita Health University
Division name
Division of Upper GI, Department of Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan
TEL
0562-93-9254
Homepage URL
ko-suda@nifty.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., LtD.
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
The Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
Fujita Health University Hospital (Aichi)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
40
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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018403
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