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

Kidney Transplantation Clinical Trial

Official title:

Utility of Stroke Volume Variation and Pulse Pressure Variation for Predicting Fluid Responsiveness in Chronic Renal Failure Patients Undergoing Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459470
• Other study ID #: 2013-03-080
• Secondary ID: 2013-03-180
• Status: Completed
• Phase: N/A
• First received: May 14, 2015
• Last updated: May 28, 2015
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• Fluid loading
fluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients

Locations

Country	Name	City	State
Korea, Republic of	Samsung Seoul Hospital, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system	predictable of stroke volume variation from FloTrac/Vigileo system for fluid responsiveness	within 5 minutes after fluid expansion	No
Primary	pulse pressure variation from philips Intelivue MP70 monitor	predictable of pulse pressure variation from philips Intelivue MP70 monitor for fluid responsiveness	within 5 minutes after fluid expansion	No