Fluid Optimization in Liver Surgery
Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Completed
CT.gov ID
NCT01627808
Collaborator
(none)
17
1
8
2.1
Study Details
Study Description
Brief Summary
The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
17 participants
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.
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Feb 1, 2012
Actual Study Completion Date
:
May 1, 2012
Outcome Measures
Primary Outcome Measures
- Stroke volume variation [at time of surgery]
Evaluation of changes in Stroke Volume Variation from Vigileo/FloTrac system during liver resection.
Secondary Outcome Measures
- Stroke volume variation [at the end of surgery]
Evaluation of changes in Stroke Volume Variation at the end of liver resection, during fluid optimization.
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Germano De Cosmo,
Phd,
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01627808
Other Study ID Numbers:
- 656/11
First Posted:
Jun 26, 2012
Last Update Posted:
Jun 26, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Germano De Cosmo,
Phd,
Catholic University of the Sacred Heart
Additional relevant MeSH terms: