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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005696
Receipt No. R000006738
Scientific Title The effect of fasting duration on the circulating blood volume
Date of disclosure of the study information 2011/06/06
Last modified on 2018/06/08

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Basic information
Public title The effect of fasting duration on the circulating blood volume
Acronym The effect of fasting duration on the circulating blood volume
Scientific Title The effect of fasting duration on the circulating blood volume
Scientific Title:Acronym The effect of fasting duration on the circulating blood volume
Region
Japan

Condition
Condition Patients undergoing elective surgery under general anesthesia
Classification by specialty
Surgery in general Obsterics and gynecology Oto-rhino-laryngology
Orthopedics Urology Anesthesiology
Neurosurgery Emergency medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of fasting duration on the circulating blood volume by measuring stroke volume variation in patients undergoing elective surgery during general anesthesia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the stroke volume variation of 2-hour fast with that of 4-hour fast to confirm the effect of fast duration on the circulating blood volume
Key secondary outcomes To assess the quantitative fluid deficits for optimal circulating blood volume

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 YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Stroke volume variation of 2-hour fast is measured with FloTracTM to estimate the circulating blood volume
Interventions/Control_2 Stroke volume variation of 4-hour fast is measured with FloTracTM to estimate the circulating blood volume
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective surgery, who met the criteria of the American Society of Anesthesiologists physical status of 1-2
Key exclusion criteria ASA physical status >=3, Obesity (BMI>30), Height>=185cm, Weight>=80Kg, Age>70 and <20
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Fujita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya, Japan
TEL 052-851-5511
Email fujitayoshihito@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihito Fujita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1 kawasumi mizuho-cho mizuho-ku, Nagoya City
TEL 052-851-5511
Homepage URL
Email fujitayoshihito@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology and Medical Crisis Management, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
2011 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://ekja.org/journal/view.php?number=8421
Number of participants that the trial has enrolled
Results
We hypothesized that the preoperative volume deficit associated with a 2 h oral intake restriction is smaller than that associated with a 4 h restriction. We tested this hypothesis using the SVV following anesthetic induction.
The primary outcome was the difference between the two groups in the volume required to achieve recovery to an SVV value of < 13%
 With respect to the primary outcome, a greater amount of infusion was required in the 4 h restriction group (2.2 ml/kg) than in the 2 h restriction group (1.7 ml/kg), without statistical significance (P = 0.378). 
Our study demonstrated that the preoperative volume deficit after a 2 h liquid intake restriction is comparable to that after a 4 h restriction.

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
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 01 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006738

Research Plan
Registered date File name
2017/10/19 The supplementary file of the manuscript for Korean Journal of Anesthesiology.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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