Kevan R. Polkinghorne, MBChB, MClinEpi, PhD, FRACP
In patients receiving hemodialysis for end-stage renal disease (ESRD), what are the efficacy and safety of an antimicrobial, antithrombotic catheter lock solution (C-MB-P) compared with heparin?
Randomized controlled trial (RCT) (Assessing Zuragen Efficacy and Safety in the Prevention and Treatment of Infection in Catheters [AZEPTIC]). ClinicalTrials.gov NCT00628680.
Unclear allocation concealment.*
Blinded (outcome assessors).*
≤ 6 months.
25 outpatient hemodialysis units in the USA.
416 patients > 18 years of age (mean age 62 y and 50% men among 407 patients who received allocated intervention) with ESRD who were receiving hemodialysis 3 times/wk through a cuffed, tunneled internal jugular venous catheter with mean baseline flow > 300 mL/min, no active infection within 30 days, and a negative preenrollment blood culture. Exclusion criteria included femoral or subclavian catheters, catheters with antithrombotic or antimicrobial coatings, thrombocytopenia, and antibiotic therapy within 14 days of enrollment.
Use of C-MB-P (n = 209) or sterile saline containing 5000 units unfractionated heparin (n = 207) to lock catheter lumens between dialysis sessions. C-MB-P was a deep-blue, aqueous solution containing 0.24 M (7.0%) sodium citrate, 0.05% methylene blue, 0.15% methylparaben, and 0.015% propylparaben.
Catheter-related bloodstream infection (CRBSI), patency failure (> 20% decrease in blood flow rate, failure to restore after 1 to 3 interventions, and removal of catheter), and device-related and severe adverse events. Secondary outcomes included all-cause mortality.
98% (intention-to-treat analysis).
The main results are in the Table. Additionally, 0 patients in the C-MB-P group (P = 0.12) had patency loss compared with 4 patients (1.9%) in the heparin group. 3 patients (1.5%) in the C-MB-P lock group had device-related adverse events compared with 0 in the heparin group (P = 0.12).
In patients receiving hemodialysis for end-stage renal disease, an antimicrobial, antithrombotic catheter lock solution reduced catheter-related bloodstream infections compared with a heparin lock solution, without increasing adverse events.
Antimicrobial, antithrombotic (C-MB-P) vs heparin lock solution for hemodialysis catheters in end-stage renal disease†
†CRBSI = catheter-related bloodstream infection; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from data in article.
‡C-MB-P = deep-blue, aqueous solution containing 0.24 M (7.0%) sodium citrate, 0.05% methylene blue, 0.15% methylparaben, and 0.015% propylparaben.
Polkinghorne KR. An antimicrobial, antithrombotic lock solution reduced catheter-related bloodstream infections in patients receiving dialysis. Ann Intern Med. ;155:JC2–11. doi: 10.7326/0003-4819-155-4-201108160-02011
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Published: Ann Intern Med. 2011;155(4):JC2-11.
Infectious Disease, Nephrology, Renal Replacement Therapy.
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