Fluid Optimization in Liver Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Germano De Cosmo, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01627808
First received: June 22, 2012
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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


Condition
Cancer of Liver

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

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


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


Enrollment: 17
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: June 22, 2012
Last Updated: June 25, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014