Fluid Oriented Therapy During Major Abdominal Surgery

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Goal Directed Therapy

Treatments: Device: FloTrac

Study type: Interventional

Funder types: Other

Identifiers

NCT03023618

PERILLI-NICE

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA 1-2 patients

Exclusion criteria

• Severe Caridiac Disease
• Renal Failure

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

control group

No Intervention group

Description:

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

case group

Active Comparator group

Description:

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

Treatment:

Device: FloTrac