UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Current Status of Nutritional Practice and education in critical ill heart failure patients: An Observational Study
Title of the study (Brief title)	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	Isao Miyajima
Organization	Chikamori Hospital Kochi University Graduate School
Division name	Department of Clinical Nutrition
Address	Okawasuji, Kochi-city, Kochi, 780-8522, Japan
TEL	088-822-5231
Email	miyajima_i@y6.dion.ne.jp

Public contact
Name of contact person	Tomoaki Yatabe
Organization	Kochi University
Division name	Department of Anesthesiology and Intensive Care Medicine
Address	Kohasu, Oko-cho, Nankoku, Kochi, 785-8505, Japan
TEL	088-880-2471
Homepage URL
Email	yatabe@kochi-u.ac.jp

Sponsor
Institute	Chikamori Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/m/pubmed/30704891/
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025030