UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Actual energy dose and protein dose in critically ill patients
Title of the study (Brief title)	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	Hiroomi Tatsumi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South 1 West 16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	htatsumi@sapmed.ac.jp

Public contact
Name of contact person	Hiroomi Tatsumi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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