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Fluid Oriented Therapy During Major Abdominal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03023618
Enrollment
180
Registered
2017-01-18
Start date
2012-01-31
Completion date
2016-05-31
Last updated
2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Goal Directed Therapy

Keywords

[G09.330.380]

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.

Interventions

DEVICEFloTrac

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA 1-2 patients

Exclusion criteria

* Severe Caridiac Disease * Renal Failure

Design outcomes

Primary

MeasureTime frame
complication rateup to 30 days postoperatively

Secondary

MeasureTime frame
Duration of hospitalizationan average of 30 days

Other

MeasureTime frame
amount of intraoperative fluidsan average of 12 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026