Fluid ORiented Therapy for yoUNg Asa 1patients | NCT03090399

Studies
Fluid ORiented Therapy for yoUNg Asa 1patients

NCT03090399

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Mar 24, 2017Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hemodynamics

Interventions

FloTrac

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Jan 2017Actual

First Submitted Date

Jan 13, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.Andrea Russo, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FloTrac	Device	For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration	case group

Measure	Description	Time Frame
prevalence of complications		up to 30 days

Measure	Description	Time Frame
days of hospitalization		up to 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1

Exclusion Criteria:

cardiac diseases
pulmonary diseases
renal diseases
metabolic disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea MD Russo	Department of Anesthesiology	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided