Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus H.

Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients were blinded to treatment allocation. The primary end-point was a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding and lock solution-related adverse events were the primary safety end points. Logistic Regression was performed to evaluate differences in PF rates among the treatments (SPSS version 13.0, IBM, USA).

Based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Calcium heparin; Citric Acid; Heparin; Minocycline; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• male and female patients;

• patients with subclavian long term central venous catheter;

• patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions).

Exclusion Criteria:

• pregnant; patients on oral coagulants; patients aged less than 18 years;

• patients aged more than 75 years