NCT02459470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

June 2, 2015

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

May 14, 2015

Last Update Submit

May 28, 2015

Conditions

Kidney Transplantation

Keywords

Fluid ResponsivenessPulse Pressure VariationStroke Volume Variation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

SVV and PPV

EXPERIMENTAL

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

Procedure: Fluid loading

Interventions

Fluid loadingPROCEDURE

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

Also known as: HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland
SVV and PPV

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- chronic renal failure patients undergoing renal transplantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Seoul Hospital, Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Gaab Soo Kim, M.D, Ph.D.

    Department of Anesthesiology and Pain medicie, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

June 2, 2015

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 2, 2015

Record last verified: 2012-12

Locations

KR(1)