UMIN-CTR Clinical Trial

Basic information
Public title	Estimation of energy requirement for patients during general anesthesia
Acronym	Energy requirement during general anesthesia
Scientific Title	Estimation of energy requirement for patients during general anesthesia
Scientific Title:Acronym	Energy requirement during general anesthesia
Region	Japan

Condition
Condition	Patients need general anesthesia for long time surgery.
Classification by specialty	Surgery in general Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Enough calories are given by indirect calorimeters during general anesthesia. Prognosis differences are compared with enough calories giving group and not enough group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Two groups will be compared duration of post operative mechanical ventilation, intensive care stay, duration of hospital stay and nutritional status.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1.amino acid, fat and glucose infusion group.
Interventions/Control_2	2.no calories group.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	General condition is good.
Key exclusion criteria	Pulmonary function is severe. cardiac function is bad.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name daizoh satoh
Organization	Tohoku University Postgraduate medical school
Division name	anesthesiology
Zip code
Address	1-1 Seiryomachi, Aoba-ku, Sendai
TEL	0227177321
Email	ds0226@fsinet.or.jp

Public contact
Name of contact person	1st name Middle name Last name daizoh satoh
Organization	Tohoku University Postgraduate medical school
Division name	anesthesiology
Zip code
Address	1-1 Seiryomachi, Aoba-ku, Sendai
TEL	022-717-7321
Homepage URL
Email	ds0226@fsinet.or.jp

Sponsor
Institute	Department of anesthesiology Tohoku University Postgraduate medical school
Institute
Department

Funding Source
Organization	Department of anesthesiology Tohoku University Postgraduate medical school
Organization
Division
Category of Funding Organization
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	2015 Year 05 Month 02 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	Completed
Date of protocol fixation	2009 Year 03 Month 20 Day
Date of IRB	2016 Year 12 Month 09 Day
Anticipated trial start date	2016 Year 02 Month 09 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 02 Day
Last modified on	2021 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006832