UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044240 |
|---|---|
| Receipt number | R000050334 |
| Scientific Title | Examination of the effect of early enteral nutrition on the post-cardiac surgery patients' clinical course |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2022/01/29 09:58:19 |
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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
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
takuya.step.by.step@gmail.com
Sponsor or person
Institute
Komaki City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050334
