Fluid ORiented Therapy for yoUNg Asa 1patients

NCT ID: NCT03090399

Last Updated: 2017-03-24

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-01-31

Brief Summary

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In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.

Detailed Description

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Conditions

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Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

patients in which standard fluid administration was applied

Group Type NO_INTERVENTION

No interventions assigned to this group

case group

patients in which fluids were administered according to FloTrac parameters

Group Type ACTIVE_COMPARATOR

FloTrac

Intervention Type DEVICE

For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration

Interventions

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FloTrac

For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA 1

Exclusion Criteria

* cardiac diseases
* pulmonary diseases
* renal diseases
* metabolic disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

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

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea MD Russo

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Other Identifiers

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FORTUNA study

Identifier Type: -

Identifier Source: org_study_id

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