UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053253 |
|---|---|
| Receipt number | R000060773 |
| Scientific Title | Effect of peripheral-central arterial pressure gradient after cardiopulmonary bypass on postoperative management in cardiovascular surgery |
| Date of disclosure of the study information | 2024/01/02 |
| Last modified on | 2023/12/31 14:46:36 |
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Basic information
Public title
Effect of peripheral-central arterial pressure gradient after cardiopulmonary bypass on postoperative management in cardiovascular surgery
Acronym
Effect of peripheral-central arterial pressure gradient after cardiopulmonary bypass on postoperative management in cardiovascular surgery
Scientific Title
Effect of peripheral-central arterial pressure gradient after cardiopulmonary bypass on postoperative management in cardiovascular surgery
Scientific Title:Acronym
Effect of peripheral-central arterial pressure gradient after cardiopulmonary bypass on postoperative management in cardiovascular surgery
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary hypothesis is that "patients with a peripheral central artery pressure gradient at the time of cardiopulmonary withdrawal require a higher dose of catecholamine postoperatively than those without a peripheral central artery pressure gradient at the time of cardiopulmonary withdrawal".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A peripheral central artery pressure gradient is defined as a difference of 10 mmHg in mean blood pressure and 25 mmHg or more in systolic blood pressure for more than 5 minutes at the time of cardiopulmonary withdrawal, and postoperative catecholamine use and length of ICU stay are compared.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult cardiovascular surgical procedures performed at our facility between April 1, 2021 and March 31, 2023 that involve the use of cardiac pulmonary bypass.
Key exclusion criteria
Cases in which it was impossible to secure the radial artery line, cases in which there was originally a peripheral-central arterial pressure gradient due to arterial stenosis, and other cases deemed inappropriate by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamada |
Organization
Chiba university hospital
Division name
Department of Anesthesiology, Pain and Palliative Care Medicine
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan
TEL
+81-43-226-2303
tyamada_violine@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamada |
Organization
Chiba university hospital
Division name
Department of Anesthesiology, Pain and Palliative Care Medicine
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan
TEL
+81-43-226-2303
Homepage URL
tyamada_violine@yahoo.co.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba university hospital
Address
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan
Tel
+81-43-226-2303
tyamada_violine@yahoo.co.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
| 2024 | Year | 01 | Month | 02 | 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
323
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Because of the large number of research subjects in this study and the extremely large amount of time and expense involved in obtaining their consent, information about this study will be made public and research subjects will be given the opportunity to refuse to participate in this study. If a research subject refuses to participate in this research, the subject will not be included in this research, unless the research results have already been published in an article or other publication at the time the refusal is made.
The following information will be posted in places where research subjects can be identified and on websites, etc., and will be readily available to research subjects.
Management information
Registered date
| 2023 | Year | 12 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060773
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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