ABSTRACT
INTRODUCTION: It has been reported that after vaccination with RNAm or viral vectors from SARS-CoV-2 a significant number of solid organ transplant recipients do not develop an effective immune response. In this scenario, the use of tixagevimab-cilgavimab was approved by the European Medicines Agency for COVID-19 prophylaxis in immunocompromised patients in March 2022. We present our experience with a group of kidney transplant recipients who received prophylactic treatment with tixagevimab-cilgavimab. MATERIAL AND METHODS: Prospective study from a cohort of kidney transplant recipients who had been previously vaccinated with 4 doses and did not achieve a satisfactory immune response to vaccination, presenting antibody titers lower than 260 BAU/mL when measured by ELISA. A total of 55 patients who received a single dose of 150mg of tixagevimab and 150mg of cilgavimab between May and September of 2022 were included in this study. RESULTS: No immediate or severe adverse reactions, including worsening of kidney function, were observed after administering the drug or during follow up. All patients who had received the drug 3 months prior presented positive antibody titers (>260 BAU/mL). Seven patients were diagnosed with COVID, and one of those patients had to be admitted to the hospital and died 5 days later from infectious complications and a suspected diagnosis of bacterial coinfection. CONCLUSIONS: In our experience, all kidney transplant recipients reached antibody titers higher than 260 BAU/mL 3 months after receiving prophylactic treatment with tixagevimab-cilgavimab with no severe or irreversible adverse reactions.
Subject(s)
Antibodies, Monoclonal, Humanized , COVID-19 , Kidney Transplantation , Humans , Male , Female , Middle Aged , Prospective Studies , COVID-19/prevention & control , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/adverse effects , Aged , Adult , Pre-Exposure Prophylaxis/methods , SARS-CoV-2 , Immunocompromised HostABSTRACT
Introduction: It has been reported that after vaccination with RNAm or viral vectors from SARS-CoV-2 a significant number of solid organ transplant recipients do not develop an effective immune response. In this scenario, the use of tixagevimab-cilgavimab was approved by the European Medicines Agency for COVID-19 prophylaxis in immunocompromised patients in March 2022. We present our experience with a group of kidney transplant recipients who received prophylactic treatment with tixagevimab-cilgavimab. Material and methods: Prospective study from a cohort of kidney transplant recipients who had been previously vaccinated with 4 doses and did not achieve a satisfactory immune response to vaccination, presenting antibody titers lower than 260 BAU/mL when measured by ELISA. A total of 55 patients who received a single dose of 150 mg of tixagevimab and 150 mg of cilgavimab between May and September of 2022 were included in this study. Results: No immediate or severe adverse reactions, including worsening of kidney function, were observed after administering the drug or during follow up. All patients who had received the drug 3 months prior presented positive antibody titers (> 260 BAU/mL). Seven patients were diagnosed with COVID, and one of those patients had to be admitted to the hospital and died 5 days later from infectious complications and a suspected diagnosis of bacterial coinfection. Conclusions: In our experience, all kidney transplant recipients reached antibody titers higher than 260 BAU/mL 3 months after receiving prophylactic treatment with tixagevimab-cilgavimab with no severe or irreversible adverse reactions.
ABSTRACT
BACKGROUND: The evidence linking low serum sodium levels with the risk of mortality in peritoneal dialysis (PD) patients is controversial. Considering the different mechanisms contributing to hyponatremia in these patients, it is conceivable that the prognostic significance of this factor may vary, according to the clinical setting. METHODS: Following a retrospective, observational design, we analyzed the association between hyponatremia and mortality in 748 patients incident on PD. We applied multivariate strategies of analysis, with the main objective of identifying subgroups of patients in whom hyponatremia could sustain different degrees of association with mortality (main outcome variable). For this purpose, we performed preliminary analyses to: (1) disclose predictors of serum sodium levels before and after (mean of first 3 months) initiation of PD (main study variable) and (2) investigate the overall prognostic significance of hyponatremia, in our patients. RESULTS: Comorbidity, hypoalbuminemia, and lower glomerular filtration rate (GFR) were main predictors of hyponatremia. Use of icodextrin was another inverse correlate of serum sodium, and the only consistent predictor of a decline of natremia, once PD was started. Multivariate analysis confirmed early hyponatremia as an independent marker of survival. However, stratified analyses showed that this association was most apparent in specific subsets, namely, hypoalbuminemic, more anemic patients with higher baseline levels of GFR and C-reactive protein and faster peritoneal solute transport rates. Other factors potentially reinforcing the prognostic significance of hyponatremia included lower lean body mass levels, nonprescription of renin-angiotensin-aldosterone system antagonists, and use of icodextrin-based PD solution. On the contrary, baseline overhydration or categorization by classic predictors of mortality (age, comorbidity, diabetes) did not appear to influence the risk pattern associated with lower serum sodium levels. CONCLUSIONS: Our results suggest that hyponatremia performs as a consistent correlate of the risk of mortality mainly in PD patients manifesting direct or indirect signs of inflammation and wasting, while this association is not apparently linked to the presence of overhydration or nominal, preexisting comorbid conditions.
Subject(s)
Hyponatremia/mortality , Peritoneal Dialysis/mortality , Adult , Aged , Female , Humans , Male , Middle Aged , Prognosis , Retrospective StudiesABSTRACT
ANTECEDENTES Y OBJETIVOS: La sobrehidratación (SH) es frecuente, y a menudo persistente, en pacientes tratados con diálisis peritoneal (DP), y mantiene una asociación controvertida con el riesgo de infección peritoneal. El objetivo principal de este estudio fue desvelar una posible asociación entre la presencia de SH y el riesgo subsiguiente de infección peritoneal por gérmenes entéricos, en una población relativamente amplia de pacientes tratados con DP. MÉTODO: Según diseño prospectivo, monitorizamos de manera sistemática la composición corporal de pacientes tratados con DP en nuestra unidad (2011-2016), buscando una posible correlación con el riesgo de peritonitis durante el seguimiento, con un interés particular en la asociación entre SH persistente (variable de estudio principal) y el riesgo de infección peritoneal por patógenos entéricos (variable resultado principal). Para el análisis tuvimos en cuenta variables demográficas, clínicas y de laboratorio con influencia potencial en el riesgo de infección peritoneal. Utilizamos técnicas de análisis multivariante para clarificar el efecto específico de diferentes parámetros de composición corporal sobre la variable resultado principal. RESULTADOS PRINCIPALES: Incluimos 139 pacientes, con seguimiento medio de 24 meses. Sesenta y tres pacientes sufrieron al menos una peritonitis, y 17 al menos una infección por gérmenes entéricos. El análisis univariante mostró una tendencia general a mayor riesgo de infección peritoneal entérica en pacientes sobrehidratados, que se hacía evidente cuando se usaba el cociente agua extracelular/agua intracelular (AEC/AIC) (p = 0,007), el cociente SH/AEC (SH/AEG) (p = 0,033), o el cociente AEC/agua corporal total (AEC/ACT) (p = 0,004), pero no cuando se usaba la SH absoluta, como variable de estudio. El análisis multivariante confirmó estas asociaciones o tendencias (RR: 3,48; IC 95%: 1,03-14,59; p = 0,046, tercil mayor versus menor para AEC/AIC, RR: 2,31; IC 95%: 0,98-6,56; p = 0,061, tercil mayor versus menor para SH/AEC, y RR: 6,33; IC 95%: 1,37-19,37; p = 0,011, tercil mayor versus menor para AEC/ACT). Por el contrario, no observamos asociación consistente entre SH y riesgo general de infección peritoneal. CONCLUSIÓN: La SH persistente asocia un riesgo significativo de infección peritoneal por patógenos entéricos, en pacientes tratados con DP
BACKGROUND: Overhydration (OH) complicates frequently the clinical course of Peritoneal Dialysis (PD) patients, and keeps a controversial association with the risk of peritoneal infection. The main objective of this study was to disclose an association between persistent OH and the risk of enteric peritonitis in a relatively large sample of patients undergoing PD. METHOD: Following a prospective design, we monitorized systematically body composition of patients treated with PD in our unit (2011-2016), searching for a correlation with the ensuing risk of peritonitis, with an emphasis on the association between persistent OH (main study variable) and the risk of infection by enteric pathogens (main outcome). Essential demographic, clinical and laboratory variables with a potential influence on the risk of peritonitis were recorded. We used multivariate survival analysis to clarify the specific effect of different body composition parameters on the main outcome. MAIN RESULTS: We included 139 patients for analysis (mean follow-up 24 months). Sixty-three patients suffered at least one peritonitis, and 17 had at least one diagnosis of enteric peritonitis. Univariate analysis disclosed a general trend to an increased risk of enteric peritonitis in overhydrated patients, as evidenced by associations of this outcome with mean extracellular water/intracellular water (ECW/ICW) (p = .007), OH/ECW (p = .033) and ECW/total body water (ECW/TBW) (p = .004) ratios, but not with absolute OH values. Multivariate analysis confirmed similar associations or trends (RR: 3.48, 95% CI: 1.03-14.59; p = .046, highest versus lowest tertile of ECW/ICW, RR: 2.31, 95% CI: 0.98-6.56; p = .061, highest versus lowest tertile of OH/ECW, and RR: 6.33, 95% CI: 1.37-19.37; p = .011, highest versus lowest tertile of ECW/TBW). On the contrary, no apparent association was detected between OH and the overall risk of peritoneal infection. CONCLUSION: Persistent overhydration portends a significant risk of peritoneal infection by enteric pathogens, among patients undergoing chronic PD
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , Peritoneal Dialysis/methods , Risk Factors , Peritoneal Dialysis/adverse effects , Peritoneum/pathology , Peritonitis/prevention & control , Prospective Studies , Body Composition , Analysis of VarianceABSTRACT
BACKGROUND: Overhydration (OH) complicates frequently the clinical course of Peritoneal Dialysis (PD) patients, and keeps a controversial association with the risk of peritoneal infection. The main objective of this study was to disclose an association between persistent OH and the risk of enteric peritonitis in a relatively large sample of patients undergoing PD. METHOD: Following a prospective design, we monitorized systematically body composition of patients treated with PD in our unit (2011-2016), searching for a correlation with the ensuing risk of peritonitis, with an emphasis on the association between persistent OH (main study variable) and the risk of infection by enteric pathogens (main outcome). Essential demographic, clinical and laboratory variables with a potential influence on the risk of peritonitis were recorded. We used multivariate survival analysis to clarify the specific effect of different body composition parameters on the main outcome. MAIN RESULTS: We included 139 patients for analysis (mean follow-up 24 months). Sixty-three patients suffered at least one peritonitis, and 17 had at least one diagnosis of enteric peritonitis. Univariate analysis disclosed a general trend to an increased risk of enteric peritonitis in overhydrated patients, as evidenced by associations of this outcome with mean extracellular water/intracellular water (ECW/ICW) (p=.007), OH/ECW (p=.033) and ECW/total body water (ECW/TBW) (p=.004) ratios, but not with absolute OH values. Multivariate analysis confirmed similar associations or trends (RR: 3.48, 95% CI: 1.03-14.59; p=.046, highest versus lowest tertile of ECW/ICW, RR: 2.31, 95% CI: 0.98-6.56; p=.061, highest versus lowest tertile of OH/ECW, and RR: 6.33, 95% CI: 1.37-19.37; p=.011, highest versus lowest tertile of ECW/TBW). On the contrary, no apparent association was detected between OH and the overall risk of peritoneal infection. CONCLUSION: Persistent overhydration portends a significant risk of peritoneal infection by enteric pathogens, among patients undergoing chronic PD.