UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043351 |
|---|---|
| Receipt number | R000049403 |
| Scientific Title | An observational study about the effects of acupoint stimulation on splanchnic hemodynamics of critically ill patients in an intensive care setting using color Doppler ultrasound sonography |
| Date of disclosure of the study information | 2021/02/18 |
| Last modified on | 2023/06/29 10:39:49 |
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Basic information
Public title
An observational study about the effects of acupoint stimulation on the splanchnic hemodynamics of critically ill patients in an intensive care setting using color Doppler ultrasound sonography
Acronym
Observation of the splanchnic hemodynamics of critically ill patients following acupoint stimulation
Scientific Title
An observational study about the effects of acupoint stimulation on splanchnic hemodynamics of critically ill patients in an intensive care setting using color Doppler ultrasound sonography
Scientific Title:Acronym
Observation of the splanchnic hemodynamics of critically ill patients following acupoint stimulation
Region
| Japan |
Condition
Condition
Critically ill patients in an intensive care setting
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effects of acupuncture stimulation on hemodynamics in the superior mesenteric artery in critically ill patients in an intensive care setting
Basic objectives2
Others
Basic objectives -Others
Observation of hemodynamic changes following acupuncture stimulation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemodynamics of the superior mesenteric artery measured using color Doppler ultrasound sonography
(blood flow volume of SMA)
Key secondary outcomes
Diameters of SMA, RI, PI, PSV, and EDV
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Inpatients in an advanced critical care center and intensive care unit at the Gifu University Hospital
2. Age >= 20 years
3. Acute coronary syndrome, heart failure, acute aortic dissection, postcardiac surgery, respiratory failure, multiple injury, brain injury, burn, renal failure, and sepsis
4. Patients who receive acupuncture treatment as decided by the attending physician
5. Patients who do not have lower leg injury and can receive acupuncture on ST36
6. Patients who provided their informed consent for this research.
Key exclusion criteria
1. Difficulty in undergoing US measurement (difficulty in maintaining resting position, abdominal injury, postabdominal surgery, and excess of intestinal gas retention)
2. Unstable hemodynamics
3. Obvious stenosis of the superior mesenteric artery
4. Remarkable arrythmia, including atrial fibrillation and other such conditions
5. Unable to use acupoint ST36 due to leg injury, burns, etc.
6. Sensory disturbance of the lower leg, including ST36 location
7. Inappropriate decision by the physician
8. Patients who did not consent to this research
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University
Division name
Department of Emergency and Disaster Medicine
Zip code
501-1194
Address
Yanagido-1-1, Gifu, Japan
TEL
058-230-6448
hideshi@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University
Division name
Department of Emergency and Disaster Medicine
Zip code
501-1194
Address
Yanagido 1-1, Gifu, Japan
TEL
058-230-6448
Homepage URL
hideshi@gifu-u.ac.jp
Sponsor or person
Institute
Department of Emergency and Disaster Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Gifu University Graduate School of Medicine
Address
Yanagido 1-1, GIfu
Tel
058-230-6059
rinri@gifu-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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of hemodynamics of the superior mesenteric artery, including blood flow volume, diameters, RI, PI, PSV, and EDV, in critically ill patients immediately after acupuncture stimulation at ST36 in clinical situation
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049403
