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

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 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


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

Value
https://center6.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