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OpenTrials
Completed

NCT Number: NCT03023618

Fluid Oriented Therapy During Major Abdominal 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.

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Key information

Conditions

Goal Directed Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-2 patients

Exclusion criteria

  • Severe Caridiac Disease
  • Renal Failure

Treatment and study plan

FloTrac

Device

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

Primary outcomes

  1. complication rate

    Time frame: up to 30 days postoperatively

Secondary outcomes

  1. Duration of hospitalization

    Time frame: an average of 30 days

Other outcomes

  1. amount of intraoperative fluids

    Time frame: an average of 12 hours

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2017
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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