UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054525 |
|---|---|
| Receipt number | R000062274 |
| Scientific Title | Association between risk and prognosis of Refeeding syndrome in high care unit |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/11/23 00:59:28 |
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Basic information
Public title
Prevalence of patients at risk of Refeeding syndrome in high care unit
Acronym
Prevalence of patients at risk of Refeeding syndrome in high care unit
Scientific Title
Association between risk and prognosis of Refeeding syndrome in high care unit
Scientific Title:Acronym
Association between risk and prognosis of Refeeding syndrome in high care unit
Region
| Japan |
Condition
Condition
Risk of refeeding syndrome
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the risk of refeeding syndromes in high-care units and identify patients needing a risk assessment for refeeding syndromes and particular nutritional therapy.
We also assess whether those risks are related to prognosis.
Basic objectives2
Others
Basic objectives -Others
This study is a retrospective observational study assessing the association between the proportion of the risk of refeeding syndrome and prognosis. None of the objectives in the Objective 2 column apply.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospital mortality
Key secondary outcomes
Proportion at risk of Refeeding syndrome, prognosis (transfer to ICU, other than discharge home), ADL
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 admitted urgently to a high care unit and stayed in hospital for more than 3 days
Key exclusion criteria
Patients included in our study more than once
Completion or exclusion according to deficiencies
Opted out and refused to participate, no active treatment
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
1197-1 Yasashicho, Asahi-ku, Yokohama, Kanagawa, 241-0811, Japan
TEL
045-366-1111
masako.suzuki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Yoshida |
Organization
St.Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL
044-977-8111
Homepage URL
https://seibu.marianna-u.ac.jp/wp-content/uploads/2023/02/5a377665717bc5cafd42794834bc5d65.pdf
minoru.yoshida@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Institute
Department
Personal name
Masako Suzuki
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine Bioethics Committee Clinical Trial Subcommittee
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/16/19/3287
Number of participants that the trial has enrolled
955
Results
A total of 955 patients were analyzed, of which 33.1%, 26.7%, 37.8%, and 2.4% were classified into the no-risk, low-risk, high-risk, and very high-risk groups, respectively. The 30-day in-hospital mortality was 4.4%, 5.5%, 5.0%, and 21.7%, respectively (Log-rank trend test: p = 0.047). In multivariable logistic regression, adjusting for sepsis, comorbidities, and age, only the very high-risk group was associated with 30-day in-hospital mortality (odds ratio: 5.54, 95% confidence interval: 1.73-17.79).
Results date posted
| 2024 | Year | 11 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062274
