UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062148 |
|---|---|
| Receipt number | R000071120 |
| Scientific Title | Investigation of Changes in Plasma Rocuronium Concentration During Cardiopulmonary Bypass and Hemodialysis. |
| Date of disclosure of the study information | 2026/07/21 |
| Last modified on | 2026/07/06 19:28:26 |
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Basic information
Public title
Investigation of Changes in Plasma Rocuronium Concentration During Cardiopulmonary Bypass and Hemodialysis.
Acronym
Investigation of Changes in Plasma Rocuronium Concentration During Cardiopulmonary Bypass and Hemodialysis.
Scientific Title
Investigation of Changes in Plasma Rocuronium Concentration During Cardiopulmonary Bypass and Hemodialysis.
Scientific Title:Acronym
Investigation of Changes in Plasma Rocuronium Concentration During Cardiopulmonary Bypass and Hemodialysis.
Region
| Japan |
Condition
Condition
Patients undergoing cardiac surgery with cardiopulmonary bypass
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the extent to Which rocuronium is removed by the hemoconcentrator during cardiopulmonary bypass
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rocuronium removal rate across the hemoconcentrator
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who were scheduled to undergo elective cardiac surgery with cardiopulmonary bypass were enrolled
Key exclusion criteria
Emergency operation
Patients with serum albumin < 2.0 g/dL
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Toyama |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata
TEL
0236285400
s-abe@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Abe |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata
TEL
0236285400
Homepage URL
s-abe@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata University Faculty of Medicine Department of Anesthesiology
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 Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata
Tel
0236285015
ikekenkyu@jm.kj.yamagata-u.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
| 2026 | Year | 07 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During cardiopulmonary bypass, ultrafiltration using a hemoconcentrator will be performed. Three samples will be collected from each participant: blood immediately before and after passage through the hemoconcentrator, and ultrafiltrate from the hemoconcentrator. Rocuronium concentrations will be measured in all samples. Clinical data will also be obtained from medical records. These data will be used to determine the removal rate of rocuronium across the hemoconcentrator and to identify factors associated with its removal.
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071120
