Defining the Relevance of Signs and Symptoms to Identify Exit Site Infection of a Hemodialysis Central Venous Catheter: A Delphi Study Protocol

Abstract

Vascular access is a potentially fatal vulnerability for hemodialysis patients, and a notable area for improvement for healthcare providers. Hemodialysis central venous catheters (HD-CVC) are associated with increased morbidity and mortality from infectious complications. Clinical practice guidelines on vascular access for hemodialysis and infection control do not provide a standard definition for infection of the HD-CVC exit site. The main aim of this protocol is to establish consensus on the signs and symptoms for preventing CVC exit site infection for patients receiving hemodialysis, based on the opinion of a panel of experts. The secondary study aim is to determine the optimum treatment approach according to the signs and symptoms of infection at the HD-CVC exit site, as prioritized by the panel of experts. For this purpose, a modified ranking-type Delphi technique will be used, with three rounds of evaluation conducted via an online questionnaire: the first two rounds will be used to prioritize, by consensus, the most relevant signs and/or symptoms of infection of the HD-CVC exit site or tunnel. Once this consensus has been achieved, a third round of evaluation will be conducted, asking the participants to ascertain the most appropriate treatment approach. The research team has drawn up a list of signs and symptoms related to infection of the HD-CVC exit site or tunnel, based on the definitions obtained from a previous systematic review. The results of the present study will enable us to design an assessment scale for HD-CVC exit sites, thus facilitating early identification and action if infection occurs. The availability of such an instrument will benefit not only clinical practice, but also research, healthcare education and training programs for professionals in this area.

Definition and clinical management of haemodialysis central venous catheter local infections (exit site and tunnel infection): An international consensus assessment

“…The rounds took place between November 2020 and March 2021. Details on the study protocol have been published elsewhere (Cobo‐Sánchez et al., 2021). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for reporting a cross‐sectional survey (Elm et al., 2007) were used (Data S1).…”

“…The research team identified a list of signs and symptoms related to ES or HD‐CVC TI from the definitions of this dimension identified in a previous literature review (Cobo‐Sánchez et al., 2023). This review included a manual review of seven relevant clinical practice guidelines on haemodialysis vascular access care and infection control, in addition to 40 documents from automated searches in different databases, identifying 25 signs/symptoms (Cobo‐Sánchez et al., 2023).…”

“…Clinical definition of the concept of ESI among international experts is heterogeneous, and varies widely in clinical practice guidelines (Ibeas et al., 2018; Lok et al., 2020; Mermel et al., 2009; O'Grady et al., 2002; Vascular Access 2006 Work Group, 2006). A recent systematic review shows a showed a high heterogeneity in the signs and symptoms used for determining ESI and tunnel infection (TI) in HD‐CVC (Cobo‐Sánchez et al., 2023). Given this conceptual variability, it is essential to reach a consensus on what are the unequivocal signs and symptoms that may lead to the suspicion of the presence of an ESI.…”

Validity of a catheter exit site clinical assessment scale for the early detection of exit site infections in patients on haemodialysis with a central venous catheter: protocol for a multicentre validation study in Spain (EXITA Study)

“…The Delphi protocol has been published recently. 35 The prioritisation thus obtained will be used to develop the preliminary version of the assessment scale we propose. 2.…”

“…After identifying the clinical signs and symptoms, by a scoping review of the literature, they will be categorised by an international panel of experts in HD-CVC exit site care, using the Delphi technique. The Delphi protocol has been published recently 35. The prioritisation thus obtained will be used to develop the preliminary version of the assessment scale we propose.…”