Administration of taurolidine-citrate lock solution for prevention of central venous catheter infection in adult neutropenic haematological patients: a randomised, double-blinded, placebo-controlled trial (TAURCAT)

Abstract

BackgroundCatheter-related bloodstream infection (CRBSI) is one of the most frequent complications in patients with cancer who have central venous catheters (CVCs) implanted and is associated with substantial morbidity and mortality. Taurolidine is a non-antibiotic agent with broad-spectrum antimicrobial activity, which has been used as a lock solution to prevent CRBSI in some settings. However, little is known about its usefulness in high-risk adult neutropenic patients with cancer. This prospective randomised clinical trial aims to test the hypothesis that taurolidine-citrate lock solution is more effective than placebo for preventing catheter infection in neutropenic haematological patients.MethodsThis study is a prospective, multicentre, randomised, double-blinded, parallel, superiority, placebo-controlled trial. Patients with haematological cancer who are expected to develop prolonged neutropenia (> 7 days) and who have a non-tunnelled CVC implanted will be randomised to receive prophylactic taurolidine-citrate-heparin solution using a lock technique (study group) or heparin alone (placebo group). The primary endpoint will be bacterial colonisation of the CVC hubs. The secondary endpoints will be the incidence of CRBSI, CVC removal, adverse events, and 30-day case-fatality rate.DiscussionThe lock technique is a preventive strategy that inhibits bacterial colonisation in the catheter hubs, which is the initial step of endoluminal catheter colonisation and the development of infection. Taurolidine is a nontoxic agent that does not develop antibiotic resistance because it acts as an antiseptic rather than an antibiotic. Taurolidine has shown controversial results in the few trials conducted in cancer patients. These studies have important limitations due to the lack of data on adult and/or high-risk neutropenic patients, the type of catheters studied (tunnelled or ports), and the lack of information regarding the intervention (e.g. dwelling of the solution, time, and periodicity of the lock technique). If our hypothesis is proven, the study could provide important solid evidence on the potential usefulness of this preventive procedure in a population at high risk of CRBSI, in whom this complication may significantly impair patient outcome.Trial registrationISRCTN, ISRCTN47102251. Registered on 9 September 2015.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2647-y) contains supplementary material, which is available to authorized users.

Taurolock versus saline 5% on preventing infection and dysfunction of hemodialysis catheters; a randomized, double blind controlled clinical trial

“…Given the infectious diseases, the formation of clots and fibrinous pods, catheter dysfunction is expected, since these issues limit their life span (15,18). Although various strategies have been considered, including heparin, antibiotics and solution, to reduce the incidence of catheter-induced infection (11,20,21), so far there is no approach to prevent catheter dysfunction and catheter-related infections, especially in people with long-term use of the catheter. However, some studies have suggested the role of thrombolytic drugs in preventing catheter inappropriate functioning (19).…”

“…Given the important role of central venous catheters in hemodialysis patients, administration of the accumulated solutions to these catheters is an important option for the prevention and treatment of catheter-related infections (4,21).…”

A Randomized, Double-Blind, Placebo-Controlled Trial (TAURCAT Study) of Citrate Lock Solution for Prevention of Endoluminal Central Venous Catheter Infection in Neutropenic Hematological Patients

“…This study has been registered in ISRCTN under identifier ISRCTN47102251. The study protocol (31) can be accessed at https://www.isrctn.com/search?qϭISRCTN47102251. The information on this trial is reported in accordance with CONSORT recommendations (see Text S1 in the supplemental material).…”

Uso do Cateter Central de Inserção Periférica em Pacientes Adultos: uma perspectiva para a enfermagem oncológica

“…Sendo o profissional de enfermagem, além de legalmente apto à sua inserção 8 , o componente da equipe que mais permanece em contato com esse público no manejo dos cuidados factíveis à prática resolutiva e qualificada, torna-se incontestável o seu profundo envolvimento com uma tecnologia tão emergente. Todavia, assim como acessos centrais tradicionais, a utilização do PICC associa-se, ainda, a uma considerável incidência de Eventos Adversos (EAs), com destaque às complicações infecciosas e trombóticas 9,10 .…”