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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039383
Receipt No. 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 2020/08/05

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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 Obsterics 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 90

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
Email 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
Email r0923ks@jichi.ac.jp

Sponsor
Institute Jichi medical university hospital
Institute
Department

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
Email 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 Open public recruiting
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
2025 Year 03 Month 31 Day
Date of closure to data entry
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
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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