NCT03023618

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

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

January 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

4.3 years

First QC Date

January 1, 2017

Last Update Submit

January 17, 2017

Conditions

Goal Directed Therapy

Keywords

[G09.330.380]

Outcome Measures

Primary Outcomes (1)

  • complication rate

    up to 30 days postoperatively

Secondary Outcomes (1)

  • Duration of hospitalization

    an average of 30 days

Other Outcomes (1)

  • amount of intraoperative fluids

    an average of 12 hours

Study Arms (2)

control group

NO INTERVENTION

patients before 2014, in which fluids were administered without FloTrac monitoring

case group

ACTIVE COMPARATOR

patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol)

Device: FloTrac

Interventions

FloTracDEVICE

Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011

case group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2 patients

You may not qualify if:

  • Severe Caridiac Disease
  • Renal Failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Valter MD Perilli, PhD

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 1, 2017

First Posted

January 18, 2017

Study Start

January 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share