- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02459470
Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation
May 28, 2015 updated by: Samsung Medical Center
Utility of Stroke Volume Variation and Pulse Pressure Variation for Predicting Fluid Responsiveness in Chronic Renal Failure Patients Undergoing Kidney Transplantation
The aim pf this prospective study is to investigate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients undergoing kidney transplantation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Optimal intraoperative fluid management guided by central venous pressure (CVP), a traditional intravascular volume status indicator has been established to improve transplanted graft function during renal transplantation.
Recently, stroke volume variation (SVV) and pulse pressure variation (PPV), dynamic preload indices derived from the arterial waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized patients and critically ill patients.
However, their usefulness in renal failure patients undergoing renal transplantation has not been investigated.
Thus, the aims of this study is to investigate accuracy of SVV and PPV for predicting fluid responsiveness in patients undergoing kidney transplantation.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Samsung Seoul Hospital, Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic renal failure patients undergoing renal transplantation
Exclusion Criteria:
- patients with cardiac arrhythmia
- patients with reduced left ventricular function (EF < 40%)
- patients with valvular heart disease
- patients intracardiac shunt
- patients with pulmonary hypertension
- patients with extensive peripheral vascular disease
- patients with preoperative use of vasopressors or inotropics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SVV and PPV
SVV(stroke volume variation): recorded using the Flotrac/Vigileo system (Edwards Lifesciences) PPV(pulse pressure variation): recorded using philips Intelivue MP70 monitors (Philips Medical System) Intervention: Other: Fluid loading using HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland |
fluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system
Time Frame: within 5 minutes after fluid expansion
|
predictable of stroke volume variation from FloTrac/Vigileo system for fluid responsiveness
|
within 5 minutes after fluid expansion
|
pulse pressure variation from philips Intelivue MP70 monitor
Time Frame: within 5 minutes after fluid expansion
|
predictable of pulse pressure variation from philips Intelivue MP70 monitor for fluid responsiveness
|
within 5 minutes after fluid expansion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gaab Soo Kim, M.D, Ph.D., Department of Anesthesiology and Pain medicie, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
May 14, 2015
First Submitted That Met QC Criteria
May 28, 2015
First Posted (Estimate)
June 2, 2015
Study Record Updates
Last Update Posted (Estimate)
June 2, 2015
Last Update Submitted That Met QC Criteria
May 28, 2015
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-03-080
- 2013-03-180 (Other Identifier: Samsung Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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