UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005696 |
|---|---|
| Receipt number | 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 17:43:53 |
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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 | Obstetrics 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
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
fujitayoshihito@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology and Medical Crisis Management, Nagoya City University Graduate School of Medical Sciences
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006738
