UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057844 |
|---|---|
| Receipt number | R000065751 |
| Scientific Title | A Study on the Predictive Ability of Dynamic Arterial Elastance for Cardiac Output Increase Following Vasopressor Administration |
| Date of disclosure of the study information | 2025/05/13 |
| Last modified on | 2025/05/13 00:29:41 |
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Basic information
Public title
A Study on the Predictive Ability of Dynamic Arterial Elastance for Cardiac Output Increase Following Vasopressor Administration
Acronym
A Study on the Predictive Ability of Dynamic Arterial Elastance for Cardiac Output Increase Following Vasopressor Administration
Scientific Title
A Study on the Predictive Ability of Dynamic Arterial Elastance for Cardiac Output Increase Following Vasopressor Administration
Scientific Title:Acronym
A Study on the Predictive Ability of Dynamic Arterial Elastance for Cardiac Output Increase Following Vasopressor Administration
Region
| Japan |
Condition
Condition
Patients scheduled for surgery under general anesthesia with planned arterial catheter insertion
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During general anesthesia, vasopressors exhibit both preload- and afterload-increasing effects. Following vasopressor administration, stroke volume (and thus cardiac output) may either increase or decrease. The study aims to investigate whether Eadyn can predict the direction of change in cardiac output induced by vasopressor use.
Basic objectives2
Others
Basic objectives -Others
This study investigates whether Eadyn can predict an increase in cardiac output following continuous vasopressor administration in response to hypotension during general anesthesia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in stroke volume before and 10 minutes after initiation of continuous vasopressor infusion (norepinephrine at 0.05 mcg/kg/min, up to a maximum of 0.1 mcg/kg/min)
Key secondary outcomes
Change in cardiac output before and 10 minutes after initiation of continuous vasopressor infusion (norepinephrine at 0.05 mcg/kg/min assumed)
Change in stroke volume and cardiac output before and 2 minutes after a single bolus of phenylephrine (0.1 mg); if multiple doses are administered, only the first dose is evaluated
Assessment of the effectiveness of continuous vasopressor infusion: whether mean arterial pressure (MAP) reaches >65 mmHg, and/or whether MAP increases by >10%
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia for surgery with planned arterial catheter insertion and intraoperative cardiac output monitoring
Key exclusion criteria
Patients with an ejection fraction <40%
Patients with atrial fibrillation
Patients with severe chronic obstructive pulmonary disease (COPD)
Patients with right heart failure
Patients with severe obesity (BMI>35)
Patients with severe underweight or cachexia (BMI<15)
Patients with preoperatively diagnosed hyperthyroidism
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | YUSUKE |
| Middle name | |
| Last name | IIZUKA |
Organization
Saitama Medical center, Jichi medical university
Division name
Department of anesthesiology and critical care medicine
Zip code
3308503
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
TEL
+81486472111
zukarinn@gmail.com
Public contact
Name of contact person
| 1st name | YUSUKE |
| Middle name | |
| Last name | IIZUKA |
Organization
Jichi medical university, saitama medical center
Division name
Department of anesthesiology and critical care medicine
Zip code
330-8503
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
TEL
+81486472111
Homepage URL
zukarinn@gmail.com
Sponsor or person
Institute
jichi medical university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Anesthesiology and Critical care medicine, Jichi medical university, Saitama medical center
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
Tel
+81486472111
s-suishin@jichi.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 13 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065751
