UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021576 |
|---|---|
| Receipt number | R000024818 |
| Scientific Title | Effects of perioperative enteral nutrition. |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/05/29 09:33:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of perioperative enteral nutrition.
Acronym
Effects of perioperative enteral nutrition.
Scientific Title
Effects of perioperative enteral nutrition.
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | Kishiko Nakai |
Organization
Hirosaki university hospital
Division name
Anesthesiology
Zip code
Address
Zaihuchou 5, Hirosaki city
TEL
0172-39-5113
kishiko_sk1064@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Erika Amanai |
Organization
Hirosaki university hospital
Division name
Anesthesiology
Zip code
Address
Zaihuchou 5, Hirosaki ctiy
TEL
0172-39-5113
Homepage URL
e.amanai@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Hirosaki university hospital
Institute
Department
Personal name
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)
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
| 2016 | Year | 03 | Month | 31 | 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
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024818
