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Central venous catheter infection prevention using a lock solution containing taurolidine, citrate, and heparin in pediatric oncology patients.


- candidate number27835
- NTR NumberNTR6688
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2017
- Secondary IDs236593526 Prinses Maxima Centrum
- Public TitleCentral venous catheter infection prevention using a lock solution containing taurolidine, citrate, and heparin in pediatric oncology patients.
- Scientific TitleThe efficacy of a lock solution containing taurolidine, citrate and heparin for the prevention of tunnelled catheter associated bloodstream infections in pediatric oncology patients, a multi-centre study
- ACRONYMCATERPILLAR
- hypothesisA decrease in the incidence rate of central line associated bloodstream infections in the investigational study group, compared to the control group.
- Healt Condition(s) or Problem(s) studiedCentral vein catheter , Pediatric cancer patients, Bloodstream infection
- Inclusion criteriaAge between 0 - <19 years
Cytological or histological proven paediatric oncology (haematologic or solid)
Hickman-Broviac-catheter or totally implantable venous access port to be inserted at the Princess Maxima Center
Parents/guardians or patient able to understand patient information and to comply with protocol procedures.
Informed consent signed by parents/guardians if patient is younger than 16 years
Informed consent signed by patient if 12 years and older
- Exclusion criteriaPrevious tunnelled central venous access device removed < 12 months
Primary immunological disorder
Contra indications: hypersensitivity to taurolidine, citrate or heparin, a history of heparin-induced thrombocytopenia.
Documented bloodstream infection at the time of catheter insertion
Insertion of the central venous access device at the same site as a previously confirmed central venous thrombosis.
Inclusion in trials with concurrent treatments (e.g. IVIG, Tropic-ALL).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-dec-2020
- Target number of participants612
- InterventionsPatients in the taurolidine, citrate and heparin lock study arm will receive a lock solution containing taurolidine 1.35%, citrate 4% and heparin 100 IU/ml (TauroLockô-Hep100). Patients in the heparin lock study arm will receive a lock solution containing the standard of care heparin 100 IU/ml. The baby and medium size totally implantable venous access ports will receive a lock volume of 1.0 ml, the adult size totally implantable venous access ports will receive 1.5 ml, and the Hickman-Broviac catheters will receive 2.0 ml (1.0 each lumen). After every manipulation of the central venous access device a new lock will be instilled, the lumen of the central venous access device will be filled up completely. Only if the central venous access device is disconnected for less than one hour, the central venous access device will be locked with 10ml NaCl 0.9%. The lock needs to be given with a minimum of one lock every four weeks, and a maximum of three locks a day. Before instillation of a new lock, the old lock will be aspirated and discarded. If aspiration is not possible, the previous lock will be flushed not faster than 1 ml per eight seconds. Then the central venous access device will be flushed with 10ml of NaCl 0.9% and the new lock will be instilled. The lock needs to be instilled slowly (not more than 1ml per five seconds
- Primary outcomeIncidence of first central line associated bloodstream infection
- Secondary outcomeTime to first CLABSI (since insertion of the CVAD)
Incidence of bacteraemia
Incidence of malfunction
Incidence of CVT
Incidence of side effects
Incidence of intensive care unit admission due to CLABSI/CVT
Incidence of death due to CLABSI/CVT
Need for and duration of systemic antibiotic treatment for CLABSI
Need for thrombolysis for CVT
Need for and reasons of CVAD removal
Incidence of cultured microorganisms during the CLABSI episodes
Total days of hospital admission due to CLABSI/CVT
Total incidence of SAEs and SUSARs
- TimepointsPatients will be followed up until first central line associated bloodstream infection, removal of the central venous access device, or death, with a maximum follow up of six months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Ceder van den Bosch
- CONTACT for SCIENTIFIC QUERIES Ceder van den Bosch
- Sponsor/Initiator Princess Maxima Center for Pediatric Oncology
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryTunnelled central venous access devices (CVAD) in pediatric oncology are associated with high rates of central line associated bloodstream infections (CLABSI).1 CLABSIs frequently result in high morbidity rates and removal of the CVAD.2 To prevent the CVAD from CLABSIs, the use of lock solutions containing taurolidine and citrate are suggested.3 Citrate has antimicrobial and anti-coagulant properties. Taurolidine has broad-spectrum antimicrobial, anti-biofilm and anti-coagulant activities, without reported antibiotic resistance.3-8 Heparin is added to the lock solution in this study for extra prevention of CVAD occlusion.9 In pediatric oncology patients, four studies showed reduced incidence rates of CLABSIs and bloodstream infections in general with the use of lock solutions containing taurolidine, citrate and in one study heparin (TCHL), compared to the standard heparin lock (HL). Similar rates of central venous thrombosis, and no serious adverse events were observed in both study arms. Side effects associated with the TCHL were taste alterations, perioral dysesthesia, and nausea.10-13 These four studies however, contained small study groups, were not randomized and/or had an open labelled design. Our aim and is to decrease the incidence of CLABSI with the TCHL. This will hopefully result in a decreased need for systemic antibiotic treatment, incidence of removal, hospital admissions, intensive care unit admissions, and deaths. This study will be performed in one of the largest pediatric oncology centres in Europe and in twenty-one shared care hospitals in the Netherlands, giving us the unique opportunity to include a large number of patients (n=610) for a double-blinded RCT on the efficacy and safety of the TCHL. The primary outcome is the incidence of first CLABSI. The patients will be monitored and locked until first CLABSI episode has resolved, removal of the CVAD, or death of the patient, with a maximum of six months.
- Main changes (audit trail)
- RECORD7-sep-2017 - 21-sep-2017


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