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

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

      • Seoul, Korea, Republic of, 135-710
        • Samsung Seoul Hospital, Samsung Medical Center

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:
  • HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland

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.

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

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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