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Central Venous Catheter Lock Solution (CVCLS)

Primary Purpose

Bacteremia

Status
Unknown status
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
citrate
heparin
Sponsored by
University Medical Center, Tuzla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteremia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of end stage renal disease

Exclusion Criteria:

  • Patients refusing randomization

Sites / Locations

  • Department of Dialysis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

citrate

heparin

Arm Description

Outcomes

Primary Outcome Measures

lower incidence of infection

Secondary Outcome Measures

lower incidence of thrombosis

Full Information

First Posted
March 13, 2009
Last Updated
March 13, 2009
Sponsor
University Medical Center, Tuzla
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1. Study Identification

Unique Protocol Identification Number
NCT00862966
Brief Title
Central Venous Catheter Lock Solution
Acronym
CVCLS
Official Title
Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Medical Center, Tuzla

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
citrate
Arm Type
Experimental
Arm Title
heparin
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
citrate
Intervention Description
comparison of different catheter lock solutions
Intervention Type
Other
Intervention Name(s)
heparin
Intervention Description
comparison of different lock solutions
Primary Outcome Measure Information:
Title
lower incidence of infection
Time Frame
1 year
Secondary Outcome Measure Information:
Title
lower incidence of thrombosis
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of end stage renal disease Exclusion Criteria: Patients refusing randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Goran Imamovic, MD, PhD
Phone
+387 61 194 131
Email
goran_imamovic@bih.net.ba
Facility Information:
Facility Name
Department of Dialysis
City
Tuzla
State/Province
TK
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Imamovic, MD,PhD
Phone
+387 61 194 131
Email
goran_imamovic@bih.net.ba
First Name & Middle Initial & Last Name & Degree
Goran Imamovic, MD, PhD

12. IPD Sharing Statement

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Central Venous Catheter Lock Solution

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