Fluid Oriented Therapy During Major Abdominal Surgery

January 17, 2017 updated by: Dr.Andrea Russo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery

In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-2 patients

Exclusion Criteria:

  • Severe Caridiac Disease
  • Renal Failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
patients before 2014, in which fluids were administered without FloTrac monitoring
Active Comparator: case group
patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol)
Device: FloTrac
Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complication rate
Time Frame: up to 30 days postoperatively
up to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalization
Time Frame: an average of 30 days
an average of 30 days

Other Outcome Measures

Outcome Measure
Time Frame
amount of intraoperative fluids
Time Frame: an average of 12 hours
an average of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Valter MD Perilli, PhD, Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 1, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PERILLI-NICE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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