UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of early nutrition on outcome in heart failure patients: A systematic review and meta-analysis
Title of the study (Brief title)	Effect of early nutrition on outcome in heart failure patients: A systematic review and meta-analysis
Region	Japan

Condition
Condition	Heart failure patients
Classification by specialty	Cardiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of early nutrition on outcome in heart failure patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of complication Readmission rate
Key secondary outcomes	Mortality Length of intensive care unit stay Lenght of hospital stay Ventilator free days

Base
Study type	Others,meta-analysis etc

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	All randomized controlled trials comparing early nutrition with late nutrition in heart failure patients are included in this study. We define early nutrition as administration of enteral/parenteral nutrition or oral intake within 24-48 hours after administration of intensive care unit or hospital.
Key exclusion criteria	We exclude studies which did not report our primary or secondary outcomes. We exclude studies which did not compare early nutrition with late nutrition. We also exclude data from reviews and animal studies.
Target sample size

Research contact person
Name of lead principal investigator	Tomoaki Yatabe
Organization	Kochi Medical School
Division name	Deaprtment of Anesthesiology and Intensive Care Medicine
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL	088-880-2471
Email	yatabe@kochi-u.ac.jp

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

Sponsor
Institute	Kochi Medical School
Institute
Department

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)

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	2015 Year 04 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We search MEDLINE,PubMed,Cochrane library,Ichushi(the Japanese database for medical journals) on 5th April 2015. Three independent reviewers screen the abstracts and titles of the studies and subsequently reviewed the full text articles for inclusion. Three independent reviewers also assess the risk of bias in individual studies as methodological quality of articles, and disagreements were resolved by discussion and consensus.

Management information
Registered date	2015 Year 04 Month 04 Day
Last modified on	2018 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019771