A Simple Clinical Tool to Help Assess Patient Volume (Flu... | NCT00599794

Studies
A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status

NCT00599794

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 24, 2008Estimated

Enrollment

84Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

United States

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

Jan 2008

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 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jan 11, 2008

First Submission Date that Met QC Criteria

Jan 23, 2008

First Posted Date

Jan 24, 2008Estimated

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

Jan 23, 2008

Last Update Posted Date

Jan 24, 2008Estimated

Name	Class
Allina Health System	OTHER

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

Patients may have actual or relative intravascular volume depletion in a number of different disease states, particularly with sepsis syndrome. However, it is clinically difficult to determine volume status without invasive monitoring, which may cause unintended complications. Our hypothesis is that we can accurately estimate central venous pressure, which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.

Detailed Description

Not provided

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

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Healty volunteers who are euvolemic.
2		Critically ill patients who will be having a central venous catheter with a monitor to measure central venous pressure placed as part of their planned care independent of this study.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older.
Healthy, euvolemic volunteers and critically ill patients who are already in an intensive care unit and who will have a central venous catheter placed as part of their planned medical treatment.

Exclusion Criteria:

Inability to use ultrasound to measure jugular vein (neck brace or bandage), "code" situation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers, then critically ill patients already in the intensive care unit who are felt to have intravascular volume depletion.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A. S. Keller, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abbott Northwestern Hospital		Minneapolis	Minnesota	55407	United States
Mayo Clinic

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided