Fluid Optimization in Liver Surgery

Cancer of Liver Clinical Trial

Official title:

Study on Fluid Optimization in Liver Surgery Trough Vigileo/FloTac System Associated to Traditional Monitoring.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627808
• Other study ID #: 656/11
• Status: Completed
• Phase: N/A
• First received: June 22, 2012
• Last updated: June 25, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cancer of Liver
• Liver Neoplasms

Locations

Country	Name	City	State
Italy	Catholic University of Sacred heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. doi: 10.1186/cc8875. Epub 2010 Feb 15. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke volume variation	Evaluation of changes in Stroke Volume Variation from Vigileo/FloTrac system during liver resection.	at time of surgery	Yes
Secondary	Stroke volume variation	Evaluation of changes in Stroke Volume Variation at the end of liver resection, during fluid optimization.	at the end of surgery	Yes