Clinical trial NCT01627808: Fluid Optimization in Liver Surgery
Official title: Study on Fluid Optimization in Liver Surgery Trough Vigileo/FloTac System Associated to Traditional Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Liver
Keywords: intraoperative monitoring
fluid management
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 17
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study were enrolled patients scheduled for elective major hepatic surgery.

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

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 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

Primary outcomes:
measure: Stroke volume variation
timeFrame: at time of surgery
Secondary outcomes:
measure: Stroke volume variation
timeFrame: at the end of surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred heart
Study officials:
affiliation: Catholic University of Sacred Heart
name: Germano De Cosmo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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. doi: 10.1016/j.amjsurg.2003.12.001.
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citation: 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. doi: 10.1097/CCM.0b013e31818b927a. No abstract available.
citation: Mayer J, Boldt J, Mengistu AM, Rohm 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. doi: 10.1186/cc8875. Epub 2010 Feb 15.
citation: 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. doi: 10.1097/CCM.0b013e31818b31f0.