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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006484
Receipt No. R000007694
Scientific Title A study of appropriate fluid volume for resuscitation (evaluation of stroke volume variation under spontaneous respiration)
Date of disclosure of the study information 2011/10/05
Last modified on 2014/07/18

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Basic information
Public title A study of appropriate fluid volume for resuscitation (evaluation of stroke volume variation under spontaneous respiration)
Acronym A study of appropriate fluid volume for resuscitation
Scientific Title A study of appropriate fluid volume for resuscitation (evaluation of stroke volume variation under spontaneous respiration)
Scientific Title:Acronym A study of appropriate fluid volume for resuscitation
Region
Japan

Condition
Condition Patients with a decrease in effective intravascular volume; dehydration, hemorrhagic shock, septic shock, and so on)
Classification by specialty
Medicine in general Surgery in general Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Firstly, we measure stroke volume variation (SVV) value when the stroke volume index dose not increase even on continuance of fluid resuscitation in the patients with spontaneous respiration . Secondary, we compare the value with the reported parameters for appropriate fluid resuscitation volume (for example, diameter of inferior vena cava, central venous pressure, lactate value, and so on). Finally, we evaluate the efficacy of measuring SVV for appropriate fluid resuscitation volume
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes No increasing of SVI under fluid resuscitation shows that the effective intravascular volume is achieved by fluid resuscitation. At this point, the following parameters are measured, vital signs, diameter of IVC, blood gas data, arterial lactate, ejection fraction, central venous pressure, ScvO2, and SVV value. We detect the best parameter for appropriate fluid resuscitation volume using receiving operating curve analysis.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measuring invasive arterial blood pressure
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) &#8805; 16 year-old
2) Patients with a decrease in effective intravascular volume and fluid resuscitation therapy ( hemorrhagic shock, dehydration, septic shock, and so on)
3) Patients with measuring invasive arterial blood pressure
Key exclusion criteria 1) Patients rejected intensive care management
2) Patients with terminal stage of malignant disease
3) Patients without informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiyoshi Hagiwara
Organization National center for global health and medicine
Division name Emergency medicine and critical care
Zip code
Address 1-21-1 Toyama Shinjyuku^ku Tokyo Japan
TEL 03-3202-7181
Email ahagiwar@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiyoshi Hagiwara
Organization National center for global health and medicine
Division name Emergency medicine and critical care
Zip code
Address 1-21-1 Toyama Shinjyuku^ku Tokyo Japan
TEL 03-3202-7181
Homepage URL
Email ahagiwar@hosp.ncgm.go.jp

Sponsor
Institute National center for global health and medicine
Institute
Department

Funding Source
Organization National center for global health and medicine
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 10 Month 05 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 Patients (n= 37) with septic shock who were fitted with FloTrac sensor. The mean of lactate value, IVC diameters, SVV values during initial fluid resuscitation vs. "stable svv" were 6.0 vs.1.8 mmol/L, 11 vs. 19 mm and 18.6 vs.8.8%, respectively (p < 0.001). Fluctations in SVV curves calculated by fast Fourier transformation resulted in a Lorentzian spectrum. The amplitude of all curves peaked at frequency = 0 and became significantly lower when "SVV stable" than during fluid therapy (1.3 vs.3.7%; p < 0.001).
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 07 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 05 Day
Last modified on
2014 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007694

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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