UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006484 |
|---|---|
| Receipt number | 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 16:49:50 |
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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) ≥ 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
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
ahagiwar@hosp.ncgm.go.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007694
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
