학술논문
Escala clínica para la detección de infección del orificio de salida del catéter venoso central para hemodiálisis: Diseño y validación
Document Type
Dissertation/Thesis
Author
Source
TDX (Tesis Doctorals en Xarxa)
Subject
Language
Spanish; Castilian
Abstract
[cat] Introducció. Les complicacions infeccioses associades als catèters venosos centrals per a hemodiàlisi (CVC-HD) són la principal causa de morbimortalitat en els pacients en tractament renal substitutiu amb aquesta tècnica. Les infeccions de l'orifici de sortida (IOS) constitueixen la primera font de bacterièmies relacionades amb el CVC-HD. A la literatura no hi ha escales clíniques específiques validades per predir-la aparició d'IOS. Objectiu. Dissenyar i validar una escala de valoració de l'orifici de sortida (OS) dels CVC-HD tunelitzats per detectar precoçment IOS. Mètode. Aquesta tesis doctoral consta de 3 fases: (1) revisió sistemàtica de la literatura per identificar signes i símptomes d'IOS i del túnel a CVC-HD a la literatura; (2) panell d'experts internacional, mitjançant tècnica Delphi per consensuar una definició d'IOS i del túnel (que es faria servir com a primera versió de l'escala), i l'actitud terapèutica a prendre; i (3) un pilotatge i estudi de capacitat predictiva per comprovar a la pràctica clínica la capacitat predictora de l'escala mitjançant un estudi de cohorts prospectiu multicèntric en 9 unitats d'hemodiàlisi. Resultats. A la revisió sistemàtica es van seleccionar 7 guies de pràctica clínica i 40 estudis primaris, identificant-se 25 signes i símptomes. L'estudi Delphi en què van participar 26 experts internacionals van consensuar una definició d'IOS amb 9 signes i símptomes. Per a l'estudi de capacitat predictiva, l'equip investigador va agrupar a 5 signes i símptomes la versió 1 de l'escala. En aquest estudi van participar 335 CVC-HD pertanyents a 310 pacients, recollint-se 515 cultius (117 infectats i 398 sans). La versió final de l'escala va incloure 3 SS que van mostrar la major capacitat predictiva: dolor a l'OS durant període interdiàlisi, hiperèmia/eritema ≥ 2 cm des de l'OS i abscés evident/exsudat purulent a l'OS. La combinació d'aquests 3 signes i símptomes va presentar un àrea sota la corba ROC 88,3% (IC95% 85,2%-91%; p<0,001), índex de Youden 0,7557 ≈1, sensibilitat 80,34% (IC95% 71,36- 87,71%), especificitat 95,23% (IC95% 92,73-97%). Conclusions. La validació de l'escala demostra bones propietats diagnòstiques i detecta aproximadament el 90% de les infeccions amb paràmetres de validesa molt adequats. La seva utilització a la pràctica detectarà de manera primerenca IOS, millorant l'objectivitat en les observacions, realitzant una classificació uniforme, que faciliti la comparació de resultats, continuïtat de cures, estalvi de costos i comparació entre investigacions sobre intervencions per a la seva prevenció/tractament.
[eng] Background. Infectious complications associated with central venous catheters for hemodialysis (CVC-HD) are the main cause of morbidity and mortality in patients undergoing renal replacement therapy with this technique. Exit-site infections (ESIs) are the primary source of CVC-HD-related bacteremia. In the literature there are no specific clinical scales validated to predict the appearance of ESI. Aim. To design and validate an assessment scale for the exit site (ES) of tunneled CVC-HDs for early detection of ESI. Method. This doctoral thesis consists of 3 phases: (1) systematic review of the literature to identify signs and symptoms of ESI and tunnel in CVC-HD in the literature; (2) international panel of experts, using the Delphi technique to agree on a definition of ESI and tunnel (which would be used as the first version of the scale), and the therapeutic attitude to be taken; and (3) a piloting and predictive capacity study to verify the predictive capacity of the scale in clinical practice through a multicenter prospective cohort study in 9 hemodialysis units. Results. In the systematic review, 7 clinical practice guidelines and 40 primary studies were selected, identifying 25 signs and symptoms. The Delphi study in which 26 international experts participated agreed on a definition of ESI with 9 signs and symptoms. For the predictive capacity study, the research team grouped version 1 of the scale into 5 signs and symptoms. 335 CVC-HD belonging to 310 patients participated in this study, collecting 515 cultures (117 infected and 398 healthy). The final version of the scale included 3 signs and symptoms that showed the greatest predictive capacity: pain in the ES during the interdialysis period, hyperemia/erythema ≥ 2 cm from the ES, and obvious abscess/purulent exudate in the ES. The combination of these 3 SS presented an area under the ROC curve (AUC) of 88.3% (95%CI 85.2%- 91%; p<0.001), Youden index 0.7557≈1, sensitivity 80.34% (95%CI 71.36- 87.71%), specificity 95.23% (95% CI 92.73-97%). Conclusions. The validation of the scale shows good diagnostic properties, detecting approximately 90% of infections with very adequate validity parameters. Its use in practice will detect ESI early, improving objectivity in observations, making a uniform classification, which facilitates the comparison of results, continuity of care, cost savings and comparison between investigations on interventions for its prevention / treatment.
[eng] Background. Infectious complications associated with central venous catheters for hemodialysis (CVC-HD) are the main cause of morbidity and mortality in patients undergoing renal replacement therapy with this technique. Exit-site infections (ESIs) are the primary source of CVC-HD-related bacteremia. In the literature there are no specific clinical scales validated to predict the appearance of ESI. Aim. To design and validate an assessment scale for the exit site (ES) of tunneled CVC-HDs for early detection of ESI. Method. This doctoral thesis consists of 3 phases: (1) systematic review of the literature to identify signs and symptoms of ESI and tunnel in CVC-HD in the literature; (2) international panel of experts, using the Delphi technique to agree on a definition of ESI and tunnel (which would be used as the first version of the scale), and the therapeutic attitude to be taken; and (3) a piloting and predictive capacity study to verify the predictive capacity of the scale in clinical practice through a multicenter prospective cohort study in 9 hemodialysis units. Results. In the systematic review, 7 clinical practice guidelines and 40 primary studies were selected, identifying 25 signs and symptoms. The Delphi study in which 26 international experts participated agreed on a definition of ESI with 9 signs and symptoms. For the predictive capacity study, the research team grouped version 1 of the scale into 5 signs and symptoms. 335 CVC-HD belonging to 310 patients participated in this study, collecting 515 cultures (117 infected and 398 healthy). The final version of the scale included 3 signs and symptoms that showed the greatest predictive capacity: pain in the ES during the interdialysis period, hyperemia/erythema ≥ 2 cm from the ES, and obvious abscess/purulent exudate in the ES. The combination of these 3 SS presented an area under the ROC curve (AUC) of 88.3% (95%CI 85.2%- 91%; p<0.001), Youden index 0.7557≈1, sensitivity 80.34% (95%CI 71.36- 87.71%), specificity 95.23% (95% CI 92.73-97%). Conclusions. The validation of the scale shows good diagnostic properties, detecting approximately 90% of infections with very adequate validity parameters. Its use in practice will detect ESI early, improving objectivity in observations, making a uniform classification, which facilitates the comparison of results, continuity of care, cost savings and comparison between investigations on interventions for its prevention / treatment.