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

AIM: To evaluate the relevance of signs and symptoms for the clinical identification of ESI and TI in HD-CVC, by means of international expert consensus, and to reach a consensus on a definition and clinical management (CM) for these infections. BACKGROUND: A recent systematic review showed a high heterogeneity in the signs/symptoms used for determining exit site infection (ESI) and tunnel infection (TI) of haemodialysis central venous catheter (HD-CVC). DESIGN: A modified Delphi ranking process was carried out between November 2020 and March 2021, consisting of four rounds using an online questionnaire with a panel of 26 experts from 12 countries. METHODS: Experts responded on the level of relevance for the identification of ESI and TI, based on a list of 22 signs/symptoms obtained from a previous systematic review, using a 4-point Likert-type scale. After reaching consensus on the signs/symptoms, they followed the same method to reach consensus on the CM. The STROBE Checklist was used to report this study. RESULTS: A high degree of consensus was reached to identify the presence of ESI based on nine signs/symptoms: presence of pain at the exit site (ES) during interdialysis period, with fever ≥38°C do not suspect other cause, local signs at the ES (inflammation, induration, swelling, hyperemia/erythema ≥2 cm from ES) and obvious abscess or purulent exudate at ES; and of TI. Likewise, 5 cm were agreed upon. CONCLUSION: This Delphi study provides international expert consensus definitions of ESI and TI in HD-CVC, laying the groundwork for the validation of an HD-CVC ES clinical assessment scale for early identification of ESI. RELEVANCE TO CLINICAL PRACTICE: In addition, this study provides a series of attitudes to consensual clinics regarding signs/symptoms of local infections in HD-CVC, which may be useful as expert opinion in clinical practice guidelines, when there is insufficient scientific evidence.

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).

INTRODUCTION: Haemodialysis patients with central venous catheter (HD-CVC) are at increased risk of exit site infections (ESIs) and catheter-related bloodstream infections, causing an increase of hospitalisation, morbidity and mortality rates. The main aim of the EXITA Study is to develop and validate an instrument for the early detection of HD-CVC ESIs. METHODS AND ANALYSIS: EXITA is a multicentre prospective cohort study to validate the proposed instrument with a sample of 457 HD-CVCs: 92 in the ESI group and 365 in the non-ESI group. Sample size was calculated using Epidat V.4.2 software, with 95% and 90% expected sensitivity and specificity, respectively, an ESI incidence around 20% and 5%-10% precision range. During each haemodialysis session, the absence or presence of each item will be assessed by nurses. If any item is present, a microbiological study of pericatheter skin smears and/or exit site exudate will be carried out. HD-CVC ESI will be diagnosed when the pericatheter skin smears and/or exit site exudate culture are positive (≥15 CFU/mL by semiquantitative Maki's technique or ≥1000 CFU/mL by Cleri's technique). To validate the scale, a logistic regression analysis will be performed: the ß coefficients of each of the signs/symptoms of the scale to be validated will be estimated. We will use logit function and calculate ESI probability=elogit ESI/1+elogit ESI. ETHICS AND DISSEMINATION: The study has been approved by the Research Ethics Committee with Medical Products of Cantabria (approval code 2019.146). We will obtain informed consent from all participants before data collection. We will publish the study results in a peer-reviewed scientific journal.