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Fluid Oriented Therapy During Major Abdominal Surgery

NCT ID: NCT03023618

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Goal Directed Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

case group

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

Group Type ACTIVE_COMPARATOR

FloTrac

Intervention Type DEVICE

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

Interventions

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FloTrac

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA 1-2 patients

Exclusion Criteria

* Severe Caridiac Disease
* Renal Failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Dr.Andrea Russo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valter MD Perilli, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Other Identifiers

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PERILLI-NICE

Identifier Type: -

Identifier Source: org_study_id

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