UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021697 |
|---|---|
| Receipt number | R000025030 |
| Scientific Title | Current Status of Nutritional Practice and education in critical ill heart failure patients: An Observational Study |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2019/02/05 07:58:02 |
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Basic information
Public title
Current Status of Nutritional Practice and education in critical ill heart failure patients: An Observational Study
Acronym
ICU-heart study
Scientific Title
Current Status of Nutritional Practice and education in critical ill heart failure patients: An Observational Study
Scientific Title:Acronym
ICU-heart study
Region
| Japan |
Condition
Condition
Heart failure patients in the ICU and CCU
Classification by specialty
| Cardiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To assess current status of nutritional practice in critical ill heart failure patients.
2. To assess the relationship between nutritional management and outcomes.
3. To assess the relationship between nutritional education and re-admission rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rehabilitation status on day of discharge
Key secondary outcomes
Arm circumference and triceps skinfold, 180-day re-admission rate, in-hospital mortality
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
Heart failure patients in ICU and CCU
Key exclusion criteria
Patients who ask us not to use their clinical information.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Miyajima |
Organization
Chikamori Hospital
Kochi University Graduate School
Division name
Department of Clinical Nutrition
Zip code
Address
Okawasuji, Kochi-city, Kochi, 780-8522, Japan
TEL
088-822-5231
miyajima_i@y6.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Yatabe |
Organization
Kochi University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi, 785-8505, Japan
TEL
088-880-2471
Homepage URL
yatabe@kochi-u.ac.jp
Sponsor or person
Institute
Chikamori Hospital
Institute
Department
Personal name
Funding Source
Organization
Kochi University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kochi University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
社会医療法人近森会近森病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/m/pubmed/30704891/
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 21 | Day |
Other
Other related information
Study design: Prospective observational study
Subject: Heart failure patients admitted to our ICU and CCU between April 1, 2016 and March 31, 2017.
Collection data:
1) Age,gender,height,weight
2) The day for ICU admission and discharge
3) Reasons for heart failure
4) The status(dead or alive) at days of discharge from ICU and hospital
5) APACHE II score and NYHA classification
6) Type and amount of nutrition received on ICU day 3,day 7, and day of discharge from the ICU.
7) Rehabilitation status.
8) 180-day re-admission rate
9) Questionnaire about nutritional education
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025030
