UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effect of early enteral nutrition on the post-cardiac surgery patients' clinical course
Acronym	Examination of the effect of early enteral nutrition on the post-cardiac surgery patients' clinical course
Scientific Title	Examination of the effect of early enteral nutrition on the post-cardiac surgery patients' clinical course
Scientific Title:Acronym	Examination of the effect of early enteral nutrition on the post-cardiac surgery patients' clinical course
Region	Japan

Condition
Condition	Cardiovascular diseases
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	On relationship between interprofessional care team rounds and outcomes on nutrition in post-cardiac surgery patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration of postoperative hospitalization
Key secondary outcomes

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	Post-cardiac surgery patients who admitted to ICU.
Key exclusion criteria	1. Not open-heart surgery 2. Death within 3 days from intensive care unit (ICU) admission 3. Receiving re-operation during the same hospitalization 4. With contraindication for enteral nutrition (EN) 5. Without EN during ICU stays 6. Experiencing venous-arterial extracorporeal membrane oxygenation during ICU stays.
Target sample size	162

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Yoshida
Organization	Komaki City Hospital
Division name	Emergency and Critical Care Medicine
Zip code	485-8520
Address	1-20 Jobushi, Komaki city, Aichi, Japan
TEL	0568-76-4131
Email	takuya.step.by.step@gmail.com

Public contact
Name of contact person	1st name Takuya Middle name Last name Yoshida
Organization	Komaki City Hospital
Division name	Emergency and Critical Care Medicine
Zip code	485-8520
Address	1-20 Jobushi, Komaki city, Aichi, Japan
TEL	0568-76-4131
Homepage URL
Email	takuya.step.by.step@gmail.com

Sponsor
Institute	Komaki City Hospital
Institute
Department

Funding Source
Organization	Komaki City Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Komaki City Hospital
Address	1-20 Jobushi, Komaki city, Aichi, Japan
Tel	0568-76-4131
Email	druginfo@komakihp.gr.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	211003
Org. issuing International ID_1	Komaki City Hospital Clinical Research Ethical Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 25 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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 04 Month 26 Day
Anticipated trial start date	2021 Year 04 Month 27 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is a single-center, retrospective observational study. Patients who was admitted to the ICU between June 2019 and March 2021 in post-cardiac surgery are eligible. Patients in the study are divided into Pre-interprofessional care team rounds (ICTR) group and Post-ICTR group. Pre-ICTR contains the patients who admitted to ICU from June 2019 to May 2020 before the start of ICTR. In contrast, Post-ICTR contains the patients who admitted to ICU from June 2020 to March 2021 after introducing of ICTR. The time for initiating enteral nutrition, the length of stay in ICU, the length of hospital stay, the incidence of new infections, and the number of complications associated with nutritional administration.

Management information
Registered date	2021 Year 05 Month 18 Day
Last modified on	2022 Year 01 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050334