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Comparative Effectiveness of 30%TSC and Heparin Lock Solution in Hemodialysis Catheters

NCT02563041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2015-09-29

No results posted yet for this study

Summary

BACKGROUND: Central venous catheters (CVC) are the only option when hemodialysis is needed for patients without definitive vascular access. However, CVC use is associated with complications such as infection, thrombosis, and dysfunction, leading to higher mortality and expenditures. The aim of this study was to compare the effectiveness of 30% trisodium citrate (TSC30%) with heparin as CVC lock solution in preventing catheter-related bloodstream infections (CRBSI) and dysfunction in hemodialysis patients. METHODS: Randomized, double-blind controlled trial comparing the event-free survival of non-tunneled CVC locked with heparin or TSC30% in adult hemodialysis patients.

Conditions

  • Catheter Related Infection

Interventions

DRUG

30% TSC

The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.

DRUG

Heparin

The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.

Sponsors & Collaborators

  • Catholic University of Pelotas

    lead OTHER

Principal Investigators

  • Maristela Bohlke, MD, PhD · Catholic University of Pelotas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563041 on ClinicalTrials.gov