Taurolidine-citrate-heparin lock reduces catheter-related bloodstream infections in intestinal failure patients dependent on home parenteral support: a randomized, placebo-controlled trial

Abstract

In patients with intestinal failure who are receiving home parenteral support (HPS), catheter-related bloodstream infections (CRBSIs) inflict health impairment and high costs. This study investigates the efficacy and safety of the antimicrobial catheter lock solution, taurolidine-citrate-heparin, compared with heparin 100 IE/mL on CRBSI occurrence. Forty-one high-risk patients receiving HPS followed in a tertiary HPS unit were randomly assigned in a double-blinded, placebo-controlled trial. External, stratified randomization was performed according to age, sex, and prior CRBSI incidence. The prior CRBSI incidence in the study population was 2.4 episodes/1000 central venous catheter (CVC) days [95% Poisson confidence limits (CLs): 2.12, 2.71 episodes/1000 CVC days]. The maximum treatment period was 2 y or until occurrence of a CRBSI or right-censoring because of CVC removal. The exact permutation tests were used to calculate values for the log-rank tests. Twenty patients received the taurolidine-citrate-heparin lock and 21 received the heparin lock, with 9622 and 6956 treatment days, respectively. In the taurolidine-citrate-heparin arm, no CRBSIs occurred, whereas 7 CRBSIs occurred in the heparin arm, with an incidence of 1.0/1000 CVC days (95% Poisson CLs: 0.4, 2.07/1000 CVC days; 0.005). The CVC removal rates were 0.52/1000 CVC days (95% Poisson CLs: 0.17, 1.21/1000 CVC days) and 1.72/1000 CVC days (95% Poisson CLs: 0.89, 3.0/1000 CVC days) in the taurolidine-citrate-heparin and heparin arm, respectively, tending to prolong CVC survival in the taurolidine arm ( = 0.06). Costs per treatment year were lower in the taurolidine arm (€2348) than in the heparin arm (€6744) owing to fewer admission days related to treating CVC-related complications ( = 0.02). In patients with intestinal failure who are life dependent on HPS, the taurolidine-citrate-heparin catheter lock demonstrates a clinically substantial and cost-beneficial reduction of CRBSI occurrence in a high-risk population compared with heparin. This trial was registered at clinicaltrials.gov as NCT01948245.

Pediatric Intestinal Failure: The Key Outcomes for the First 100 Patients Treated in a National Tertiary Referral Center During 1984–2017

“…Overall, CRBSI rates had a significantly declining incidence toward recent years. By 2013 and thereafter, every patient has received taurolidine CVC locks reported to prevent CRBSIs also in other pediatric IF centers, a result confirmed recently in a randomized placebo‐controlled trial in adult patients with IF . We have used commercially manufactured 3‐in‐1 PN bags since 2011, likely also contributing to our currently low CRBSI rates .…”

“…By 2013 and thereafter, every patient has received taurolidine CVC locks reported to prevent CRBSIs also in other pediatric IF centers, 7 a result confirmed recently in a randomized placebo-controlled trial in adult patients with IF. 34 We have used commercially manufactured 3-in-1 PN bags since 2011, likely also contributing to our currently low CRBSI rates. 35 Despite the standardized CVC care policy, certain individuals with SBS experienced repeated culturepositive line infections, which may also originate from inflamed small intestine with dysfunctional epithelial barrier of dilated remaining small bowel.…”

Taurolidine–citrate lock solution for the prevention of central line‐associated bloodstream infection in paediatric haematology–oncology and gastrointestinal failure patients with high baseline central‐line associated bloodstream infection rates

“…involving 19 GI patients on home parenteral nutrition, CLABSI was reduced from 8.6 to 1.1 per 1000 catheter‐days with TCS usage . In a randomised controlled trial of 41 adult GI patients on home parenteral nutrition on taurolidine–citrate–heparin versus heparin, no CLABSI occurred in the TCS arm versus 1 per 1000 catheter‐days in the heparin arm . It has been proposed that TCS should only be used in home parenteral nutrition patients with high baseline rates of CLABSI.…”

JPEN Journal Club 43. Stratification

“…Catheter‐related bloodstream infections (CRBSIs) are an oft‐encountered complication in patients receiving home parenteral nutrition (HPN). Two randomized clinical trials (RCTs) have shown that, compared with the use of heparin, when taurolidine is used in the catheter lock, fewer CRBSIs occur . Taurolidine, derived from taurine, interferes with the adherence of microorganisms, thereby preventing their subsequent local growth .…”

“…Two randomized clinical trials (RCTs) have shown that, compared with the use of heparin, when taurolidine is used in the catheter lock, fewer CRBSIs occur. 1,2 Taurolidine, derived from taurine, interferes with the adherence of microorganisms, thereby preventing their subsequent local growth. 3 As should be appreciated, however, comparing taurolidine to heparin only demonstrates the relative efficacy of 2 interventions; 4 if heparin is actually harmful, we do not know if taurolidine is more effective than doing nothing.…”