UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of perioperative enteral nutrition.
Title of the study (Brief title)	Effects of perioperative enteral nutrition.
Region	Japan

Condition
Condition	perioperative states.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of perioperative enteral nutrition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood suger, keton body.
Key secondary outcomes	Lactate, pH and base excess of blood gas analysis, gastric pH, gastric fluid volume, concentration of insulin, mean blood pressures, heart rates, urine volume.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Use acetate ringer with 1% glucose.
Interventions/Control_2	Use acetate ringer with 1% glucose and OS-1.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Elective non-abdominal operation over three hours.
Key exclusion criteria	1. Patients with past history of gastrointestinal surgery. 2. patients undergoing high calorie infusion therapy. 3. patients with diabetes melitus or other endocrine dysfunctions.
Target sample size	40

Research contact person
Name of lead principal investigator	Kishiko Nakai
Organization	Hirosaki university hospital
Division name	Anesthesiology
Address	Zaihuchou 5, Hirosaki city
TEL	0172-39-5113
Email	kishiko_sk1064@yahoo.co.jp

Public contact
Name of contact person	Erika Amanai
Organization	Hirosaki university hospital
Division name	Anesthesiology
Address	Zaihuchou 5, Hirosaki ctiy
TEL	0172-39-5113
Homepage URL
Email	e.amanai@gmail.com

Sponsor
Institute	Department of Anesthesiology, Hirosaki university hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Anesthesiology, Hirosaki university hospital
Organization
Division
Category of Funding Organization
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	2016 Year 03 Month 31 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 03 Month 31 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2016 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024818