UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042799 |
|---|---|
| Receipt number | R000048398 |
| Scientific Title | Effect of low-dose landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery: A retrospective study |
| Date of disclosure of the study information | 2020/12/21 |
| Last modified on | 2020/12/21 13:44:51 |
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Basic information
Public title
Effect of low-dose landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery: A retrospective study
Acronym
Effect of low-dose landiolol on hemodynamics in patients undergoing OPCAB
Scientific Title
Effect of low-dose landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery: A retrospective study
Scientific Title:Acronym
Effect of low-dose landiolol on hemodynamics in patients undergoing OPCAB
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effect of landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heart rate
Key secondary outcomes
systolic blood pressure, diastolic blood pressure, stroke volume index, mixed venous oxygen saturation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients in which landiolol was administered during OPCAB surgery
Key exclusion criteria
patients who were under an implanted or temporary pacemaker, and who were defibrillated during the operation were excluded
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Seo |
Organization
Kokura Memorial Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
802-8555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
0935112000
seo-k@kokurakinen.or.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Kuribayashi |
Organization
Kokura Memorial Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
802-8555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
0935112000
Homepage URL
j_kuriba0416@yahoo.co.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital
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
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
Tel
0935112000
rinsyo@kokurakinen.or.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
| 2020 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
http://www.kokurakinen.or.jp/bumon/rinsyoukenkyu/ippan/pdf/ippan-05-02.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://nsas.anesth.or.jp/App/Datura/sm/61/session/P2-23.html#P2-23-6
Number of participants that the trial has enrolled
55
Results
In OPCAB surgery, low-dose landiolol was used and reduced HR with decreased SAP regardless of preoperative EF. The lower value of DAP in low EF patients may have been attributed to the demographic higher incidence of intra-aortic balloon pumping.
Results date posted
| 2020 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients in which landiolol was administered during OPCAB surgery
Participant flow
We retrospectively reviewed the anesthesia records
Adverse events
None
Outcome measures
heart rate, systolic blood pressure, diastolic blood pressure, cardiac index, stroke volume index, mixed venous oxygen saturation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we retrospectively reviewed the relevant anesthesia records in our hospital about the hemodynamic parameters
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048398
