Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition

Y Wouters, M Theilla, P Singer, S Tribler, P B Jeppesen, L Pironi, L Vinter-Jensen, H H Rasmussen, F Rahman, G J A Wanten, Y Wouters, M Theilla, P Singer, S Tribler, P B Jeppesen, L Pironi, L Vinter-Jensen, H H Rasmussen, F Rahman, G J A Wanten

Abstract

Background: The catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter-related bloodstream infections (CRBSIs) in home parenteral nutrition patients.

Aims: To compare the effectiveness and safety of taurolidine and saline.

Methods: This multicentre double-blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre-existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre-existing catheter group, separately.

Results: We randomised 105 patients, of which 102 were analysed as modified intention-to-treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009). In the pre-existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03-1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug-related adverse events were rare and generally mild.

Conclusions: In the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre-existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs.

Trial registration: Clinicaltrials.gov, identifier: NCT01826526.

© 2018 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Enrollment and follow‐up. *Patients were excluded from the modified intention‐to‐treat analysis because no effectiveness assessments were available after the baseline visit. †Patients were excluded from the per‐protocol analysis because they either did not meet eligibility criteria or did not complete the trial before the planned visits with complete test results in accordance with the protocol. Some patients were excluded from the per‐protocol analysis for more than one reason but were included in only one exclusion category
Figure 2
Figure 2
Kaplan‐Meier survival curves of modified intention‐to‐treat population. CRBSI, catheter‐related bloodstream infection; CVAD, catheter‐related access device. Kaplan‐Meier survival curves presenting the time to CRBSIs (A‐C) and time to CVAD removals due to CRBSIs (D‐F) with CVADs locked with 2% taurolidine (green continuous line) versus 0.9% saline (blue interrupted line) in the new catheter group, pre‐existing catheter group, and the groups combined. Survival curves were compared using log‐rank testing

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