UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039383 |
|---|---|
| Receipt number | R000044909 |
| Scientific Title | An identification of blood and urea markers to find promptly the dehydration in patients undergoing general anesthesia. |
| Date of disclosure of the study information | 2020/02/04 |
| Last modified on | 2023/01/27 20:38:01 |
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Basic information
Public title
An identification of blood and urine markers to find promptly the dehydration in patients undergoing general anesthesia.
Acronym
Search for dehydration markers
Scientific Title
An identification of blood and urea markers to find promptly the dehydration in patients undergoing general anesthesia.
Scientific Title:Acronym
Search for dehydration markers
Region
| Japan |
Condition
Condition
Patients undergoing non-cardiac surgery with general anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Orthopedics | Oral surgery | Neurosurgery |
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The cause of dehydration during surgery includes blood loss, vascular expansion due to anesthetic agents, or extravascular loss due to inflammation. It is essential for anesthesiologists to administer an appropriate fluid infusion to patinents, though quite challenging to identify the dehydration during general anesthesia because of the lack of thirstiness. Low blood pressure, tachycardia, scarce urine output, or respiratory variation of arterial pulse are well-known markers related to dehydration, however, these are also affected by other causes, thus more specific markers are needed.
Electrolyte free water clearance (Cw) reflects the degree of re-absorption in renal collecting duct and may possibly relate to the dehydration. The aim of present study is to inspect the relationship between Cw and dehydration and second, the relationship between dehydration and urine osmolality, urine gravity, urine sodium/potassium ratio, serum blood urea nigrogen/creatinine ration, serum osmolality. Finally, we aim at searching which marker is the best one to identify the dehydration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between Cw and the body weight difference between body weight of operation day and the one of the day before.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective non-cardiac surgery with general anesthesia
Key exclusion criteria
cardiac surgery, urgent surgery, renal failure, hemodialysis, medication with diuretics, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, patients without urethral balloon, menstruating women, regional anesthesia, patients without any blood test during operation and postoperatively.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Kenzaburo |
| Middle name | |
| Last name | Sugimoto |
Organization
Jichi medical university hospital
Division name
Department of Anaesthesiology and Critical Care Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke-City, Tochigi
TEL
0285-58-7383
r0923ks@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kenzaburo |
| Middle name | |
| Last name | Sugimoto |
Organization
Jichi medical university hospital
Division name
Department of Anaesthesiology and Critical Care Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke-City, Tochigi
TEL
0285-58-7383
Homepage URL
r0923ks@jichi.ac.jp
Sponsor or person
Institute
Jichi medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Eisai pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi medical university hospital clinical research support administration
Address
3311-1, Yakushiji, Shimotsuke-City, Tochigi
Tel
0285-58-8933
rinri@jichi.ac.jp
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
| 2020 | Year | 02 | Month | 04 | 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
| 2020 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 17 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
urine gravity, urine osmolality, urine sodium and potassium, serum blood urea nitrogen, creatinine, sodium osmolality
age, sex, body height, body weight, body mass index, renal failure, hemodialysis, medication, menstrual
Management information
Registered date
| 2020 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044909
