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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036607
Receipt No. 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

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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
Email 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
Email webmaster_senri@senri.saiseikai.or.jp

Sponsor
Institute Osaka Saiseikai Senri Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041704

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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