UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051094 |
|---|---|
| Receipt number | R000058268 |
| Scientific Title | Prospective observational study of plasma cortisol levels and postoperative circulatory failure and organ damage in cardiac major vascular surgery underl cardiopulmonary bypass |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2023/05/18 11:31:31 |
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Basic information
Public title
Prospective observational study of plasma cortisol levels and postoperative circulatory failure and organ damage in cardiac major vascular surgery underl cardiopulmonary bypass
Acronym
Prospective observational study of plasma cortisol levels and postoperative circulatory failure and organ damage in cardiac major vascular surgery underl cardiopulmonary bypass
Scientific Title
Prospective observational study of plasma cortisol levels and postoperative circulatory failure and organ damage in cardiac major vascular surgery underl cardiopulmonary bypass
Scientific Title:Acronym
Prospective observational study of plasma cortisol levels and postoperative circulatory failure and organ damage in cardiac major vascular surgery underl cardiopulmonary bypass
Region
| Japan |
Condition
Condition
Cardiovascular disease requiring surgery under cardiopulmonary bypass
Classification by specialty
| Vascular surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between the severity of postoperative circulatory and organ failure in cardiac major vascular surgery under cardio pulmonary bypass and plasma cortisol levels at ICU admission.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma cortisol level, VIS score, SOFA score
Key secondary outcomes
28-day mortality, Ventilator time, ICU length of stay, Arrhythmia, Acute renal failure, Tracheostomy, Infection, Biomarkers (I-FABP, IL-6, procalcitonin, endotoxin activity)
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
Heart disease (valvular disease, coronary artery disease, short circuit, tumor, endocarditis, pericarditis, vascular disease)
Key exclusion criteria
Case of extracorporeal membrane oxygenation theapy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Ichinomiya |
Organization
Nagasaki university graduate school of biomedical sciences
Division name
department of anesthesiology and intensive care medicine
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7370
taiga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Iwasaki |
Organization
Nagasaki university graduate school of biomedical sciences
Division name
department of anesthesiology and intensive care medicine
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7370
Homepage URL
n-iwasaki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
crinical resarch senter, Nagasaki university hospital
Address
1-7-1, Sakamoto, Nagasaki, Japan
Tel
095-819-7726
rinshou7726@umin.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
| 2023 | Year | 05 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study of plasma cortisol levels and postoperative circulatory failure and organ failure in cardiac major vascular surgery under cardiopulmonary bypass
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058268
