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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032103
Receipt No. R000036627
Scientific Title Actual energy dose and protein dose in critically ill patients
Date of disclosure of the study information 2018/04/04
Last modified on 2018/04/04

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Basic information
Public title Actual energy dose and protein dose in critically ill patients
Acronym Actual energy dose and protein dose in critically ill patients
Scientific Title Actual energy dose and protein dose in critically ill patients
Scientific Title:Acronym Actual energy dose and protein dose in critically ill patients
Region
Japan

Condition
Condition critically ill patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consider actual energy dose and protein dosage in seriously ill patients.
Basic objectives2 Others
Basic objectives -Others In the acute phase of critically ill patients, it is said that the amount of energy should be administered moderately, with a greater dosage of protein. However, there are few studies on the amount of energy and protein actually administered. Review the actual dosage in patients entering ICU retrospectively.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes energy dose and protein dosage
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 Among critically ill patients who entered our ICU during the period January 1, 2015 to December 31, 2017, patients who stayed in the ICU for more than 8 days
Key exclusion criteria Under 18 years old
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroomi Tatsumi
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address South 1 West 16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email htatsumi@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroomi Tatsumi
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address South 1 West 16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Homepage URL
Email htatsumi@sapmed.ac.jp

Sponsor
Institute Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2018 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2017 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The amount of energy actually administered was 23 kcal/kg/day which was more than the recommended amount, but the amount of protein was 0.9 g/kg/day which was less than the recommended amount (both median values).

Management information
Registered date
2018 Year 04 Month 04 Day
Last modified on
2018 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036627

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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