A Non-invasive Approach to the Assessment of Volume Statu... | NCT00398736

Studies
A Non-invasive Approach to the Assessment of Volume Status in Mechanically Ventilated Septic Patients.

NCT00398736

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 15, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Severe Sepsis
Septic Shock

Interventions

sonographic measurement of inferior caval vein diameter

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

Jul 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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 13, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 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

Jul 14, 2009

Last Update Posted Date

Jul 15, 2009Estimated

Description Module

Brief Summary

To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated septic patients.

Volume assessment in mechanically ventilated patients with inflammation is of major importance to guide fluid therapy. The researchers investigated whether measurement of caval vein diameter correlates with invasively assessed volume-based hemodynamic parameters.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
sonographic measurement of inferior caval vein diameter	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-90
presence of severe sepsis and septic shock
invasive hemodynamic monitoring using the picco system

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients with sepsis

Sampling Method

Probability Sample

Name	Affiliation	Role
Joerg C Dr. Schefold, MD	Charite University Medicine	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided