UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032103 |
|---|---|
| Receipt number | 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 20:28:03 |
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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
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
htatsumi@sapmed.ac.jp
Sponsor or person
Institute
Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036627
