UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051839 |
|---|---|
| Receipt number | R000059068 |
| Scientific Title | Effect of an enteral nutrition enriched with omega-3 fatty acid in critically ill patients: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/06 10:21:16 |
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Basic information
Public title
Effect of an enteral nutrition enriched with omega-3 fatty acid in critically ill patients: a systematic review and meta-analysis
Acronym
Effect of an enteral nutrition enriched with omega-3 fatty acid in critically ill patients: a systematic review and meta-analysis
Scientific Title
Effect of an enteral nutrition enriched with omega-3 fatty acid in critically ill patients: a systematic review and meta-analysis
Scientific Title:Acronym
Effect of an enteral nutrition enriched with omega-3 fatty acid in critically ill patients: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
critically ill patients
Classification by specialty
| Endocrinology and Metabolism | Surgery in general | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the risks and benefits of enteral nutrition enriched with omega-3 fatty acid in crtically ill patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality
Key secondary outcomes
ICU length of stay
Incidence of infection
Ventilator duration
All adverse events
Change in muscle mass during hospitalization or after discharge
Physical function assessment at discharge or thereafter up to 1 year after discharge
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
critically ill patients
Key exclusion criteria
child
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University Hospital
Division name
Department of Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
knakamura-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Nagatomo |
Organization
University of Tsukuba Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3900
Homepage URL
nagatomo.k0724@gmail.com
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Kensuke Nakamura
Funding Source
Organization
No
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
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3900
nagatomo.k0724@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
| 2023 | Year | 08 | Month | 07 | 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
3000
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A systematic review and meta-analysis.
RCTs of enteral nutrition fortified with omega-3 fatty acids in critically ill patients were extracted and analyzed from MEDLIME, ICHUSHI, and CENTRAL.
Management information
Registered date
| 2023 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059068
