Central Venous Catheter Lock Solution | NCT00862966

Studies
Central Venous Catheter Lock Solution

NCT00862966

Sponsor

University Medical Center, Tuzla

Status

Unknown status

Last Update Posted

Mar 17, 2009Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Bacteremia

Interventions

citrate
heparin

Countries

Bosnia and Herzegovina

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

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

Not provided

First Submitted Date

Mar 13, 2009

First Submission Date that Met QC Criteria

Mar 13, 2009

First Posted Date

Mar 17, 2009Estimated

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 13, 2009

Last Update Posted Date

Mar 17, 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

The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
citrate	Experimental		Other: citrate
heparin	Active Comparator		Other: heparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
citrate	Other	comparison of different catheter lock solutions	citrate

Measure	Description	Time Frame
lower incidence of infection		1 year

Measure	Description	Time Frame
lower incidence of thrombosis		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of end stage renal disease

Exclusion Criteria:

Patients refusing randomization

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

Name	Role	Phone	Extension	Email
Goran Imamovic, MD, PhD	Contact	+387 61 194 131		goran_imamovic@bih.net.ba

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dialysis		Tuzla	TK	75000	Bosnia and Herzegovina

Condition Browse Module

MeSH Terms

ID	Term
D016470	Bacteremia

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019343	Citric Acid
D006493	Heparin

Ancestor Terms

ID	Term
D002951	Citrates
D014233	Tricarboxylic Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided