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Fluid Optimization in Liver Surgery

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ClinicalTrials.gov Identifier: NCT01627808
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
Germano De Cosmo, Catholic University of the Sacred Heart

Brief Summary:
The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.

Condition or disease
Cancer of Liver

Detailed Description:

To reduce bleeding, hepatectomies are performed with low central pressure (CVP) combined with extrahepatic control flow.

This management can lead hemodynamic instability and reduction in oxygen delivery so an advanced monitoring should be used.

This study analyzes hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.


Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study on Fluid Optimization in Liver Surgery Trough Vigileo/FloTac System Associated to Traditional Monitoring.
Study Start Date : September 2011
Primary Completion Date : February 2012
Study Completion Date : May 2012



Primary Outcome Measures :
  1. Stroke volume variation [ Time Frame: at time of surgery ]
    Evaluation of changes in Stroke Volume Variation from Vigileo/FloTrac system during liver resection.


Secondary Outcome Measures :
  1. Stroke volume variation [ Time Frame: at the end of surgery ]
    Evaluation of changes in Stroke Volume Variation at the end of liver resection, during fluid optimization.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In this study were enrolled patients scheduled for elective major hepatic surgery.
Criteria

Inclusion Criteria:

  • ASA I-III

Exclusion Criteria:

  • Cirrhosis
  • systolic ventricular contractility or diastolic relaxation alterations
  • ischemic or valvular diseases
  • absence of sinusal rhythm
  • impaired renal function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627808


Locations
Italy
Catholic University of Sacred heart
Rome, Italy
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Germano De Cosmo, PhD Catholic University of Sacred Heart

Publications:

Responsible Party: Germano De Cosmo, Phd, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01627808     History of Changes
Other Study ID Numbers: 656/11
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Germano De Cosmo, Catholic University of the Sacred Heart:
intraoperative monitoring
fluid management

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases