UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036607 |
|---|---|
| Receipt number | R000041704 |
| Scientific Title | Effects of enteral nutrition with high-protein in critically ill patients |
| Date of disclosure of the study information | 2019/04/26 |
| Last modified on | 2019/04/26 13:01:26 |
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Basic information
Public title
Effects of enteral nutrition with high-protein in critically ill patients
Acronym
Effects of enteral nutrition with high-protein in critically ill patients
Scientific Title
Effects of enteral nutrition with high-protein in critically ill patients
Scientific Title:Acronym
Effects of enteral nutrition with high-protein in critically ill patients
Region
| Japan |
Condition
Condition
Ventilated patients in the intensive care units
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of effects of enteral nutrition with high-protein in critically ill patients with normal nutrition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum prealbumin concentration 7,14,28 days after the beginning of the study
Key secondary outcomes
ventilator-free days,ICU length of stay,hospital length of stay,
SOFA score, serum albumin, white blood cell count, lymphocyte count, CRP, total cholesterol, urea nitrogen, creatinine 7,14,28 days after the beginning of the study,
total daily dose of insulin,
total energy, and protein dose during enteral nutrition
total amount of administration of blood products (albumin, globulin et al)
complications(vomiting, diarrhea, kidney injury, ventilator-associated pneumonia)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Peptamen Intense
Interventions/Control_2
Sanet N3
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)admission to the ICU
2)need for intubation and mechanical intubation
3)an expected duration of ventilation more than 6 days
4)unnecessary for a renal replacement therapy
5)patients with consent for included in the study
Key exclusion criteria
1)contraindication for enteral nutrient with high quantity of proteins
2)BMI more than 30, less than 18.5
3)denial of intensive care by a patients or a patient family
4)allergy to milk, soy, lactose
5)need for total parenteral nutrition
6)need for a renal replacement therapy
7)Patients judged as inappropriate to perform the present trial by the j the doctor
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Hibiki |
| Middle name | |
| Last name | Serizawa |
Organization
Osaka Saiseikai Senri Hospital
Division name
Senri Critical Care Medical Center
Zip code
565-0862
Address
1-1-6,Tsumkumodai,Suita-city,Osaka-fu
TEL
06-6871-0121
webmaster_senri@senri.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Hibiki |
| Middle name | |
| Last name | Serizawa |
Organization
Osaka Saiseikai Senri Hospital
Division name
Senri Critical Care Medical Center
Zip code
565-0862
Address
1-1-6,Tsumkumodai,Suita-city,Osaka-fu
TEL
06-6871-0121
Homepage URL
http://www.senri.saiseikai.or.jp/hospital/department/trial/c_research/list.html
webmaster_senri@senri.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Senri Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Saiseikai Senri Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Saiseikai Senri Hospital institutional review board
Address
1-1-6,Tsumkumodai,Suita-city,Osaka-fu
Tel
06-6871-0121
webmaster_senri@senri.saiseikai.or.jp
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
| 2019 | Year | 04 | Month | 26 | 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
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 04 | 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
| 2019 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
