Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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).
    

Intervention name(s): Heparin Lock Solution; Trissodium Citrate 30%; Minocycline-EDTA 30 mg/ml - 3 mg/ml
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Just after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.; ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.; ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
Other intervention name(s): Hemofol (Traade Mark); CitraLock(Trade Mark); Cath-Safe (Trade Mark)
Intervention MeSH terms: Minocycline; Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: renal dialysis