UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012238 |
|---|---|
| Receipt number | R000014213 |
| Scientific Title | Changes in perioperative renal function,albumin,and lactic acid by preoperative oral rehydretion |
| Date of disclosure of the study information | 2013/11/08 |
| Last modified on | 2013/11/07 21:07:14 |
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Basic information
Public title
Changes in perioperative renal function,albumin,and lactic acid by preoperative oral rehydretion
Acronym
Changes in perioperative renal function,albumin,and lactic acid by preoperative oral rehydretion
Scientific Title
Changes in perioperative renal function,albumin,and lactic acid by preoperative oral rehydretion
Scientific Title:Acronym
Changes in perioperative renal function,albumin,and lactic acid by preoperative oral rehydretion
Region
| Japan |
Condition
Condition
patients undergoing general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate that preoperative oral rehydration changes renal function, albumin, lactic acid in perioperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)lactic acid
2)albumin
3)creatinine
4)blood urea nitrogen
5)creatinine clearance
Key secondary outcomes
Base
Study type
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drink 500ml(Arginaid Water®) three hours before anesthesia
Interventions/Control_2
Give an intravenous drip Soldem 3A three hours before anesthesia
Interventions/Control_3
Drink 500ml water including SOLITA-T GRANULES No.3 three hours before anesthesia
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ASA Physical status 1 or 2
Key exclusion criteria
Obesity(BMI>30)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Imagawa |
Organization
TAKATSUKI RED CROSS HOSPITAL
Division name
Anesthesiology
Zip code
Address
1-1-1 Abuno, Tatsuki, Oosaka
TEL
072-696-0571
k_imagawa_0621@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Imagawa |
Organization
TAKATSUKI RED CROSS HOSPITAL
Division name
Anesthesiology
Zip code
Address
1-1-1 Abuno, Takatsuki, Oosaka
TEL
072-696-0571
Homepage URL
k_imagawa_0621@yahoo.co.jp
Sponsor or person
Institute
TAKATSUKI RED CROSS HOSPITAL
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
高槻赤十字病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 08 | 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 | 11 | Month | 07 | Day |
Last modified on
| 2013 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014213
