NCT00862966

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

March 17, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

March 13, 2009

Last Update Submit

March 13, 2009

Conditions

Bacteremia

Outcome Measures

Primary Outcomes (1)

  • lower incidence of infection

    1 year

Secondary Outcomes (1)

  • lower incidence of thrombosis

    1 year

Study Arms (2)

citrate

EXPERIMENTAL
Other: citrate

heparin

ACTIVE COMPARATOR
Other: heparin

Interventions

citrateOTHER

comparison of different catheter lock solutions

citrate
heparinOTHER

comparison of different lock solutions

heparin

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of end stage renal disease

You may not qualify if:

  • Patients refusing randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dialysis

Tuzla, TK, 75000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Bacteremia

Interventions

Citric AcidHeparin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsGlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Goran Imamovic, MD, PhD

CONTACT

+387 61 194 131goran_imamovic@bih.net.ba

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 17, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Last Updated

March 17, 2009

Record last verified: 2009-03

Locations

BO(1)