NCT00749619

Brief Summary

Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
Last Updated

September 9, 2008

Status Verified

September 1, 2008

Enrollment Period

1.3 years

First QC Date

September 7, 2008

Last Update Submit

September 8, 2008

Conditions

End Stage Renal DiseaseHemodialysis

Keywords

Tunneled Cuffed CatheterCatheter Lock SolutionCatheter Related Bacteremia

Study Arms (3)

A

EXPERIMENTAL
Other: Catheter Lock Solution Taurolidine and Citrate

B

EXPERIMENTAL
Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin

C

NO INTERVENTION
Other: Catheter Lock Solution : Heparin

Interventions

Catheter Lock Solution Taurolidine and CitrateOTHER
A
Catheter Lock Solution :Taurolidine and Citrate and HeparinOTHER
B
Catheter Lock Solution : HeparinOTHER
C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis patients with new TCC
  • Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, Israel

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Citric AcidHeparin

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Purpose
PREVENTION
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2008

First Posted

September 9, 2008

Study Start

May 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 9, 2008

Record last verified: 2008-09

Locations

IL(1)