NCT01627808

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

June 22, 2012

Last Update Submit

June 25, 2012

Conditions

Cancer of Liver

Keywords

intraoperative monitoringfluid management

Outcome Measures

Primary Outcomes (1)

  • Stroke volume variation

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

    at time of surgery

Secondary Outcomes (1)

  • Stroke volume variation

    at the end of surgery

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ASA I-III

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred heart

Rome, Italy

Location

Related Publications (8)

  • 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.

    PMID: 3196088BACKGROUND

  • 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.

    PMID: 11941976BACKGROUND

  • 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.

    PMID: 15006570BACKGROUND

  • 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.

    PMID: 15194628BACKGROUND

  • 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.

    PMID: 15073709BACKGROUND

  • 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.

    PMID: 18941314BACKGROUND

  • 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.

    PMID: 20156348BACKGROUND

  • 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.

    PMID: 18824912BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Germano De Cosmo, PhD

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 26, 2012

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

IT(1)