UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007223 |
|---|---|
| Receipt number | R000008504 |
| Scientific Title | Effect of fluid loading on changes in the left ventricular volume and stroke volume variation in hemodialysis patients: A prospective study using real-time three-dimensional transesophageal echocardiography and Flotrac/Vigileo system |
| Date of disclosure of the study information | 2012/02/06 |
| Last modified on | 2018/09/21 16:52:27 |
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Basic information
Public title
Effect of fluid loading on changes in the left ventricular volume and stroke volume variation in hemodialysis patients: A prospective study using real-time three-dimensional transesophageal echocardiography and Flotrac/Vigileo system
Acronym
Effect of fluid loading on changes in the left ventricular volume and stroke volume variation in hemodialysis patients
Scientific Title
Effect of fluid loading on changes in the left ventricular volume and stroke volume variation in hemodialysis patients: A prospective study using real-time three-dimensional transesophageal echocardiography and Flotrac/Vigileo system
Scientific Title:Acronym
Effect of fluid loading on changes in the left ventricular volume and stroke volume variation in hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with end-stage renal disease require strict perioperative fluid management. We investigated fluid loading-induced changes in hemodynamics and left ventricular volume in hemodialysis patients using real-time three-dimensional transesophageal echocardiograpy and FloTac/Vigileo system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stroke volume variation
left ventricular end-diastolic volume
left ventricular end-systolic volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fluid loading
Interventions/Control_2
Control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective peripheral vascular procedure
Key exclusion criteria
Patients were excluded from consideration if there were arrhythmia (atrial fibrillation or frequent ventricular ectopy) or preoperative significant left ventricular systolic dysfunction (ejection fraction<50%) or esophageal pathology that increased the risks associated with the placement of the ultrasound transducer (esophageal stricture, tracheoesophageal fistula, esophageal trauma, and previous esophageal or gastric surgery).
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Kanda |
Organization
Asahikawa Medical College
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
h.kanda0629@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanda Hirotsugu |
Organization
Asahikawa Medical College
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaoka-Higash, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Homepage URL
h.kanda0629@nifty.com
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical College.
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
旭川医科大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 06 | 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
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 | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 02 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008504
| Research Plan | |
|---|---|
| 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 |
