Hemodynamic Monitoring With Mixed Venous Saturation | NCT00303043

Studies
Hemodynamic Monitoring With Mixed Venous Saturation

NCT00303043

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Dec 30, 2009Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Critically Ill

Interventions

Mixed venous saturation monitoring

Countries

Italy

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 2009

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

Mar 2006

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Mar 14, 2006

First Submission Date that Met QC Criteria

Mar 14, 2006

First Posted Date

Mar 15, 2006Estimated

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

Dec 29, 2009

Last Update Posted Date

Dec 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 study the investigators aim to evaluate the utility of a continuous mixed venous saturation monitoring compared to a clinical examination in a group of critically ill patients.

Detailed Description

We will compare possible difference in terms of sensibility and specificity regarding the continuous mixed venous saturation monitoring compared to clinical examination in a group of critically ill patients.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1			Procedure: Mixed venous saturation monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixed venous saturation monitoring	Procedure	Mixed venous saturation monitoring	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critically ill patients with a central venous catheter

Exclusion criteria:

Patients with pulmonary catheter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Critically ill patients with a central venous catheter

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Davide Chiumello, MD	Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena		Milan	mi	20145	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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