UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017393 |
|---|---|
| Receipt number | R000006832 |
| Scientific Title | Estimation of energy requirement for patients during general anesthesia |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2021/08/18 08:09:27 |
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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
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
ds0226@fsinet.or.jp
Sponsor or person
Institute
Department of anesthesiology
Tohoku University Postgraduate medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006832
