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NCT03023618 Clinical Trial

Fluid Oriented Therapy During Major Abdominal Surgery

Goal Directed Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03023618
Other study ID # PERILLI-NICE
Secondary ID
Status Completed
Phase N/A
First received January 1, 2017
Last updated January 17, 2017
Start date January 2012
Est. completion date May 2016

Study information
Verified date January 2017
Source Policlinico Universitario Agostino Gemelli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ASA 1-2 patients

Exclusion Criteria:

- Severe Caridiac Disease

- Renal Failure

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Policlinico Universitario Agostino Gemelli

Outcome
Type Measure Description Time frame Safety issue
Other amount of intraoperative fluids an average of 12 hours
Primary complication rate up to 30 days postoperatively
Secondary Duration of hospitalization an average of 30 days
See also
  Status Clinical Trial Phase
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Completed NCT03012919 - Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery N/A
Completed NCT04814966 - Feasibility of Extended Non-invasive Haemodynamic Monitoring in the PACU