UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010816 |
|---|---|
| Receipt number | R000012662 |
| Scientific Title | Efficacy of preoperative oral-rehydration therapy in preventing perioperative fluid overload and endothelial dysfunction |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2014/09/08 11:26:18 |
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Basic information
Public title
Efficacy of preoperative oral-rehydration therapy in preventing perioperative fluid overload and endothelial dysfunction
Acronym
Efficacy of preoperative oral-rehydration therapy in preventing perioperative fluid overload
Scientific Title
Efficacy of preoperative oral-rehydration therapy in preventing perioperative fluid overload and endothelial dysfunction
Scientific Title:Acronym
Efficacy of preoperative oral-rehydration therapy in preventing perioperative fluid overload
Region
| Japan |
Condition
Condition
Adult planned surgical patients
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Anesthesiology |
| Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that preoperative oral-rehydration therapy prevents perioperative excessive infusion and fluid accumulation by preserving endothelial and glycocalyx functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraoperative Fluid Balance
Key secondary outcomes
Perioperative changes of body fluid measured with Bioelectrical impedance analysis
Plasma concentrations of endothelial and glycocaryx injury markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Preoperative oral rehydration therapy
Interventions/Control_2
Preoperative fasting
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for upper GI tract surgery (except for esophageal surgery) at Yokohama City University Hospital or Yokohama City University Medical Center, admitting to OR of which from 8:30 to 9:30 am
Key exclusion criteria
ASA class 3 and 4, GERD, History of upper GI surgery, Obstruction of GI tract, Obesity(>=BMI35), Anticipated airway difficulties, Emergency operations, 90years old and older, Arrythmia,implanted cardiac pacemakers, Preoperative parenteral infusion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoyasu Kurahashi |
Organization
Yokohama City University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawaku, Yokohamashi, Kanagawaken, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama CIty University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawaku, Yokohamashi, Kanagawaken, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine, Yokohama CIty University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | 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
| 2013 | Year | 05 | Month | 28 | Day |
Last modified on
| 2014 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012662
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
