NCT03090399

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

3.5 years

First QC Date

January 13, 2017

Last Update Submit

March 20, 2017

Conditions

Hemodynamics

Keywords

Goal Directed Fluid Therapy

Outcome Measures

Primary Outcomes (1)

  • prevalence of complications

    up to 30 days

Secondary Outcomes (1)

  • days of hospitalization

    up to 12 weeks

Study Arms (2)

control group

NO INTERVENTION

patients in which standard fluid administration was applied

case group

ACTIVE COMPARATOR

patients in which fluids were administered according to FloTrac parameters

Device: FloTrac

Interventions

FloTracDEVICE

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

case group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1

You may not qualify if:

  • cardiac diseases
  • pulmonary diseases
  • renal diseases
  • metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Andrea MD Russo

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 13, 2017

First Posted

March 24, 2017

Study Start

January 1, 2012

Primary Completion

July 1, 2015

Study Completion

January 1, 2017

Last Updated

March 24, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share