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

History of Changes

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:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

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

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:

Stephenson KR, Steinberg SM, Hughes KS, Vetto JT, Sugarbaker PH, Chang AE. Perioperative blood transfusions are associated with decreased time to recurrence and decreased survival after resection of colorectal liver metastases. Ann Surg. 1988 Dec;208(6):679-87.

Torzilli G, Makuuchi M, Inoue K. The vascular control in liver resection: revisitation of a controversial issue. Hepatogastroenterology. 2002 Jan-Feb;49(43):28-31. Review.

Smyrniotis V, Kostopanagiotou G, Theodoraki K, Tsantoulas D, Contis JC. The role of central venous pressure and type of vascular control in blood loss during major liver resections. Am J Surg. 2004 Mar;187(3):398-402.

Choukèr A, Schachtner T, Schauer R, Dugas M, Löhe F, Martignoni A, Pollwein B, Niklas M, Rau HG, Jauch KW, Peter K, Thiel M. Effects of Pringle manoeuvre and ischaemic preconditioning on haemodynamic stability in patients undergoing elective hepatectomy: a randomized trial. Br J Anaesth. 2004 Aug;93(2):204-11. Epub 2004 Jun 11.

Bein B, Worthmann F, Tonner PH, Paris A, Steinfath M, Hedderich J, Scholz J. Comparison of esophageal Doppler, pulse contour analysis, and real-time pulmonary artery thermodilution for the continuous measurement of cardiac output. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):185-9.

Hickey R. How good is arterial pulse contour (LiDCO) and the esophageal Doppler monitor (HemoSonic) in measuring left ventricular stroke volume during venous occlusion? Crit Care Med. 2008 Nov;36(11):3103-4.

Mayer J, Boldt J, Mengistu AM, Röhm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. Epub 2010 Feb 15.

Marquez J, McCurry K, Severyn DA, Pinsky MR. Ability of pulse power, esophageal Doppler, and arterial pulse pressure to estimate rapid changes in stroke volume in humans. Crit Care Med. 2008 Nov;36(11):3001-7.

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 May 16, 2013

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