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CompletedNCT01627808Updated Jun 26, 2012

Fluid Optimization in Liver Surgery

An observational study in Cancer of Liver, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-06-26.

Sponsored by Catholic University of the Sacred Heart · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
17
Ages
30 Years to 70 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Cancer of Liver

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Keywords

  • intraoperative monitoring
  • fluid management
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In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 17 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

In this study were enrolled patients scheduled for elective major hepatic surgery.

Inclusion criteria

  • ASA I-III

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
17 participants (actual)
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What researchers measure

Primary outcomes

  1. Stroke volume variation

    Evaluation of changes in Stroke Volume Variation from Vigileo/FloTrac system during liver resection.

    Time frame: at time of surgery

Secondary outcomes

  1. Stroke volume variation

    Evaluation of changes in Stroke Volume Variation at the end of liver resection, during fluid optimization.

    Time frame: at the end of surgery

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Study locations

1 site
  • Catholic University of Sacred heart
    Rome, Italy
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References and documents

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. doi: 10.1097/00000658-198812000-00002. PubMed 3196088 ↗
  • 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. PubMed 11941976 ↗
  • 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. PubMed 15006570 ↗
  • Chouker A, Schachtner T, Schauer R, Dugas M, Lohe 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. doi: 10.1093/bja/aeh195. Epub 2004 Jun 11. PubMed 15194628 ↗
  • 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. doi: 10.1053/j.jvca.2004.01.025. PubMed 15073709 ↗
  • 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. PubMed 18941314 ↗
  • 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. PubMed 20156348 ↗
  • 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. PubMed 18824912 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01627808
Lead sponsor
Catholic University of the Sacred Heart
Responsible party
Germano De Cosmo (Phd, Catholic University of the Sacred Heart) — Principal investigator
First posted
Jun 26, 2012
Start date
Sep 2011
Primary completion
Feb 2012
Completion
May 2012
Last update
Jun 26, 2012

Study contacts

Germano De Cosmo, PhD
principal investigator · Catholic University of Sacred Heart

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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