Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
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.
Methods: 75 CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at
 the Integrated Centre of Nephrology (Guarulhos, Brazil) will be randomized 1:1:1 to receive
 M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations are M-EDTA 30 mg/ml/3 mg/ml,
 C 30% (C) and H 1,000 U/ml and both investigators and patients are blinded to treatment
 allocation. The primary end-point is a 10% reduction in HD blood flow rates (35ml). The
 frequency of CRBSI will be recorded. Poor Flow Rate (event/1,000 catheter-day) and CRBSI Rate
 (event/1,000 catheter-day) will be calculated in each arm. Bleeding and lock solution-related
 adverse events are also the primary safety end points and their rates (events/1,000
 catheter-day) will be calculated. Logistic Regression will be performed to evaluate
 differences in PF, CRBSI, Bleeding and lock solution-related adverse events rates among the
 treatments (SPSS version 13.0, IBM, USA).
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