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Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation

Primary Purpose

Kidney Transplantation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluid loading
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Transplantation focused on measuring Fluid Responsiveness, Pulse Pressure Variation, Stroke Volume Variation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Seoul Hospital, Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SVV and PPV

Arm Description

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

Outcomes

Primary Outcome Measures

stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system
predictable of stroke volume variation from FloTrac/Vigileo system for fluid responsiveness
pulse pressure variation from philips Intelivue MP70 monitor
predictable of pulse pressure variation from philips Intelivue MP70 monitor for fluid responsiveness

Secondary Outcome Measures

Full Information

First Posted
May 14, 2015
Last Updated
May 28, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02459470
Brief Title
Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation
Official Title
Utility of Stroke Volume Variation and Pulse Pressure Variation for Predicting Fluid Responsiveness in Chronic Renal Failure Patients Undergoing Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation
Keywords
Fluid Responsiveness, Pulse Pressure Variation, Stroke Volume Variation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SVV and PPV
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Fluid loading
Other Intervention Name(s)
HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland
Intervention Description
fluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients
Primary Outcome Measure Information:
Title
stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system
Description
predictable of stroke volume variation from FloTrac/Vigileo system for fluid responsiveness
Time Frame
within 5 minutes after fluid expansion
Title
pulse pressure variation from philips Intelivue MP70 monitor
Description
predictable of pulse pressure variation from philips Intelivue MP70 monitor for fluid responsiveness
Time Frame
within 5 minutes after fluid expansion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaab Soo Kim, M.D, Ph.D.
Organizational Affiliation
Department of Anesthesiology and Pain medicie, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Seoul Hospital, Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation

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