UMIN-CTR Clinical Trial

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
Email	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
Email	takaharu0866@yahoo.co.jp

Sponsor
Institute	Osaka Police Hospital
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)

IRB Contact (For public release)
Organization	Osaka Police Hospital
Address	10-31 Kitayamacho, Tennoji-ku, Osaka
Tel	0667716051
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056001