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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007223
Receipt No. 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

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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
Email 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
Email h.kanda0629@nifty.com

Sponsor
Institute Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical College.
Institute
Department

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008504

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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