UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049172 |
|---|---|
| Receipt number | R000056001 |
| Scientific Title | Efficacy of nutrition protocol in the cardiac care unit |
| Date of disclosure of the study information | 2022/10/10 |
| Last modified on | 2022/10/10 11:57:33 |
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Basic information
Public title
Efficacy of nutrition protocol in the cardiac care unit
Acronym
Efficacy of nutrition protocol in the cardiac care unit
Scientific Title
Efficacy of nutrition protocol in the cardiac care unit
Scientific Title:Acronym
Efficacy of nutrition protocol in the cardiac care unit
Region
| Japan |
Condition
Condition
Cardiovascular patients
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy before and after the introduction of the nutrition protocol in the CCU
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to start enteral nutrition
Key secondary outcomes
nutritional adequacy, protein adequacy
Gastrointestinal dysfunction
duration of stay in the CCU
duration of mechanical ventilation
duration of hospital stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Nutritional treatment according to the nutritional protocol
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
1) Patients admitting the CCU after cardiovascular surgery
2) Patients admitting the CCU for the purpose of treating cardiovascular disease
3) Patients admitting the CCU with mechanical ventilation (invasive or non-invasive)
4) Patients who were expected to remain unable to take oral nutrition for at least 48 h
1) or 2) or 3), and 4)
Key exclusion criteria
1) Patients suspicious of refeeding syndrome
2) Patients < 18 years of age
3) Patients who do not consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Higuchi |
| Middle name | |
| Last name | Yoshiharu |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
5430035
Address
10-31 Kitayamacho, Tennoji-ku, Osaka
TEL
0667716051
yhiguchi.ja@gmail.com
Public contact
Name of contact person
| 1st name | Hayashi |
| Middle name | |
| Last name | Takaharu |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
5430035
Address
10-31 Kitayamacho, Tennoji-ku, Osaka
TEL
09041497927
Homepage URL
takaharu0866@yahoo.co.jp
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka Police Hospital
Address
10-31 Kitayamacho, Tennoji-ku, Osaka
Tel
0667716051
yhiguchi.ja@gmail.com
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
| 2022 | Year | 10 | Month | 10 | 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 | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 10 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056001
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
