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. 2023 Mar 21;13(3):e069760.
doi: 10.1136/bmjopen-2022-069760.

CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients

Ceder Hildegard van den Bosch  1 , Yvette Loeffen  2 , Alida F W van der Steeg  3 , Jan-Tom T van der Bruggen  4 , Florine N J Frakking  4 , Marta Fiocco  3   5 , Cornelis P van de Ven  3 , Marc H W A Wijnen  3 , Marianne D van de Wetering  3
Affiliations

CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients

Ceder Hildegard van den Bosch et al. BMJ Open. .

Abstract

Introduction: The efficacy of taurolidine containing lock solutions for the prevention of central line-associated bloodstream infections (CLABSI) in paediatric oncology patients is still unknown. If the taurolidine-citrate-heparin lock appears to decrease the incidence of CLABSIs, we hope to increase the quality of life of children with cancer by subsequently reducing the central venous access device (CVAD)-removal rates, dispense of antibiotics, hospital admissions and incidence of severe sepsis resulting in intensive care unit admission.

Methods and analysis: This assessor-blinded randomised controlled trial including 462 patients was designed to compare the taurolidine-citrate-heparin lock to the heparin-only lock for the prevention of CLABSIs in paediatric oncology patients. Patients receiving their first CVAD at the Princess Máxima Centre for Paediatric Oncology, Utrecht, the Netherlands, are eligible for inclusion. The primary outcome of this study is the incidence of first CLABSIs from CVAD insertion until the end of the study, maximum follow-up of 90 days. An intention-to-treat and a per-protocol analysis will be performed. An interim analysis will be performed after the inclusion of 50% of the patients. The results of the interim analysis and overall conduct of the trial will be discussed by a data safety monitoring board.

Ethics and dissemination: The medical ethics committee NedMec, Utrecht, the Netherlands, has approved this research (number 20/370). Written informed consent for participation in this trial and publication of the trial data is obtained from all patients and/or their parents/guardians. The results of this trial will be published in a peer-reviewed journal and the data will be made available on reasonable request after publication of the main results manuscript.

Trial registration numbers: NTR6688; NCT05740150.

Keywords: Infection control; PREVENTIVE MEDICINE; Paediatric oncology.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Schedule of enrolment, interventions and assessments. *Number of visits depending on the treatment schedule and unexpected admissions. Aim is to insert the lock after each visit with a maximum of once weekly. CLABSI, central line-associated bloodstream infections; CVT, central venous thrombosis; CVAD, central venous access device; HL, heparin-only lock; TCHL, taurolidine-citrate(-heparin) lock solutions.
See this image and copyright information in PMC

References

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