Optimised versus standard automated peritoneal dialysis regimens pilot study (OptiStAR): A randomised controlled crossover trial.

BACKGROUND: The continuous global rise of end-stage kidney disease creates a growing demand of economically beneficial home-based kidney replacement therapies such as peritoneal dialysis (PD). However, undesirable absorption and exposure of peritoneal tissues to glucose remain major limitations of PD. METHODS: We compared a reference (standard) automated PD regimen 6 × 2 L 1.36% glucose (76 mmol/L) over 9 h with a novel, theoretically glucose sparing (optimised) prescription consisting of 'ultrafiltration cycles' with high glucose strength (126 mmol/L) and 'clearance cycles' with ultra-low, physiological glucose (5 mmol/L) for approximately 40% of the treatment time. Twenty-one prevalent PD patients underwent the optimised regimen (7 × 2 L 2.27% glucose + 5 × 2 L 0.1% glucose over 8 h) and the standard regimen in a crossover fashion. Six patients were excluded from data analysis. RESULTS: Median glucose absorption was 43 g (IQR 41-54) and 44 g (40-55) for the standard and optimised intervention, respectively (p = 1). Ultrafiltration volume, weekly Kt/V creatinine and urea were significantly improved during optimised interventions, while no difference in sodium removal was detected. Post hoc analysis showed significantly improved ultrafiltration efficiency (ml ultrafiltration per gram absorbed glucose) during optimised regimens. No adverse events were observed except one incidence of drain pain. CONCLUSION: Optimised treatments were feasible and well tolerated in this small pilot study. Despite no difference in absorbed glucose, results indicate possible improvements of ultrafiltration efficiency and small solute clearances by optimised regimens. Use of optimised prescriptions as glucose sparing strategy should be evaluated in larger study populations.

Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial.

BACKGROUND: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having "UF cycles" using a higher glucose concentration, and "Clearance cycles" using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes. METHODS: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 × 2 L 1.36% over 9 h) or optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. DISCUSSION: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04017572. Registration date: July 12, 2019, retrospectively registered.

Peritonitis en diálisis peritoneal. Epidemiología, factores de riesgo, incorporación del BACTECÕ a la recolección del cultivo tradicional y mortalidad a largo plazo / Peritonitis in peritoneal dialysis. Epidemiology, risk factors, inclusion of BACTECÕ in traditional culture systems, and long-term mortality

INTRODUCCIÓN: La peritonitis es la principal complicación en los pacientes en diálisis peritoneal (DP), con repercusión en su morbi-mortalidad. El objetivo de este estudio fue analizar la epidemiología, factores de riesgo, incorporación del BACTEC y mortalidad relacionada a peritonitis en DP. MATERIAL Y MÉTODOS: Estudio de cohorte retrospectivo. Se incluyeron todos los pacientes que iniciaron DP entre 1992 y 2017, en el Hospital Privado Universitario de Córdoba. RESULTADOS: En total se analizaron 159 pacientes, 63 (39.62%), tuvo por lo menos un episodio de peritonitis y 96 (60.38%), ninguno. La tasa global de peritonitis fue de 0.37 episodios/paciente-año. Los factores de riesgo para peritonitis fueron: antecedente de Hemodiálisis previo a DP (OR=3.18, IC95%=1.41-7.14; p=0.0051) e hipoalbuminemia(OR=3.10, IC95%=1.36-7.06; p=0.0071). La incorporación del BACTEC incrementó el porcentaje de cultivos positivos (de 73.55% a 96.55%; p=0.0076). Los aislamientos más frecuentes fueron: SAMS (23.66%) y BGN (20,61%). Existieron diferencias entre el periodo 1992-2006 y 2006-2017 en aislamientos de Candida (1.49% y 9.38%, p=0.0448) y el grupo otras bacterias (1.49% y 9.38%, p=0.0448). Los pacientes con peritonitis tuvieron mayor mortalidad (55.56% contra 38.58%, p=0.0480), aunque en el análisis multivariado, ésta no fue un factor de riesgo independiente de mortalidad. CONCLUSIÓN: Los factores de riesgo para peritonitis fueron haber recibido hemodiálisis previa a DP e hipoalbuminemia. La incorporación del BACTEC incrementó el porcentaje de cultivos positivos. Después del 2006 existió un incremento de aislamientos de cándidas y del grupo otras bacterias. La peritonitis no fue un factor de riesgo independiente de mortalidad a largo plazo

INTRODUCTION: Peritonitis is the most common complication in peritoneal dialysis (PD), with an effect on morbidity and mortality. The aim of this study was to analyze epidemiology, risk factors, implementation of the BACTEC™ blood culture system and mortality of peritoneal dialysis-associated peritonitis. METHODS: In this retrospective, cohort study, all the patients who started PD between 1992 and 2017 at Hospital Privado Universitario de Córdoba (Córdoba Private Medical College Hospital) were included. RESULTS: The total number of patients was 159, 63 (39.62%) of which had suffered from peritonitis at least once and 96 (60.38%) had never had it. The global peritonitis rate was 0.37 episodes per patient-year. The risk factors for peritonitis were the following: a history of hemodialysis before PD (OR=3.18; CI 95%=1.41-7.14; p=0.0051) and hypoalbuminemia (OR=3.10; CI 95%=1.36-7.06; p=0.0071). The implementation of the BACTEC™ system increased the percentage of positive blood cultures (from 73.55% to 96.55%; p=0.0076). The most frequent isolates were MSSA (23.66%) and GNB (20.61%). Differences were found between the 1992-2006 and 2006-2017 periods in the Candida isolates (1.49% and 9.38%; p=0.0448) and the "other bacteria" group (1.49% and 9.38%; p=0.0448). Although peritonitis patients showed a higher mortality rate (55.56% versus 38.58%; p=0.0480), the multivariate analysis revealed that this condition was not a mortality independent risk factor. CONCLUSION: The risk factors for peritonitis were hemodialysis prior to PD and hypoalbuminemia. The use of the BACTEC™ system increased the percentage of positive blood cultures. After 2006 the number of isolates from the Candida and the "other bacteria" groups was higher. Peritonitis was not a long-term mortality independent risk factor

High-dose steroid treatment increases free water transport in peritoneal dialysis patients.

The water channel aquaporin-1 (AQP1) is the molecular counterpart of the ultrasmall pore that mediates free water transport during peritoneal dialysis (PD). Proof-of-principle studies performed in rats have shown that treatment with corticosteroids upregulates the expression of AQP1 in the peritoneal capillaries, causing a significant increase in free water transport. Whether such a beneficial effect could be observed in end-stage renal disease patients treated by PD remains unknown. Peritoneal transport parameters were evaluated in three patients on PD, shortly before and after living-donor renal transplantation and treatment with high-dose methylprednisolone (1.0-1.2 g/m(2)). As compared with pre-transplantation values, the post-transplantation test revealed an ∼2-fold increase in the sodium sieving and ultrasmall pore ultrafiltration volume, suggesting an effect on AQP1 water channels. In contrast, there was no change in the parameters of small solute transport. The direct involvement of AQP1 in these changes is suggested by the expression of glucocorticoid receptors in the human peritoneum and the presence of conserved glucocorticoid response elements in the promoter of the human AQP1 gene.