Fluid Optimization in Liver Surgery | NCT01627808

Studies
Fluid Optimization in Liver Surgery

NCT01627808

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

Jun 26, 2012Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Cancer of Liver

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Feb 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 22, 2012

First Submission Date that Met QC Criteria

Jun 25, 2012

First Posted Date

Jun 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2012

Last Update Posted Date

Jun 26, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Germano De Cosmo, Phd, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke volume variation	Evaluation of changes in Stroke Volume Variation from Vigileo/FloTrac system during liver resection.	at time of surgery

Secondary Outcomes

Measure	Description	Time Frame
Stroke volume variation	Evaluation of changes in Stroke Volume Variation at the end of liver resection, during fluid optimization.	at the end of surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Germano De Cosmo, PhD	Catholic University of Sacred Heart	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University of Sacred heart		Rome			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3196088	Background	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.
11941976	Background

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases