Study on the Infection Risk of Long Dwell Period Catheter... | NCT00136097

Studies
Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients

NCT00136097

Sponsor

University Hospital, Ghent

Status

Terminated

Last Update Posted

Dec 28, 2007Estimated

Enrollment

142

Phase

Not Applicable

Conditions

Burns

Interventions

Placement of a silver impregnated central venous catheter

Countries

Belgium

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

Dec 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 26, 2005Estimated

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 19, 2007

Last Update Posted Date

Dec 28, 2007Estimated

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

This is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity.

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

142

Name	Type	Description	Arm Group Labels	Other Names
Placement of a silver impregnated central venous catheter	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of colonisation of the central venous catheter at the moment of removal

Secondary Outcomes

Measure	Description	Time Frame
Incidence of a catheter related blood stream infection during the presence of the catheter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Burn patient
Placement of a new trilumen central venous catheter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kirsten Colpaert, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium