Glucose-containing peritoneal dialysis solutions may exacerbate metabolic abnormalities and increase cardiovascular risk in diabetic patients. Here, we examined whether a low-glucose regimen improves metabolic control in diabetic patients undergoing peritoneal dialysis. Eligible patients were randomly assigned in a 1:1 manner to the control group (dextrose solutions only) or to the low-glucose intervention group (IMPENDIA trial: combination of dextrose-based solution, icodextrin and amino acids; EDEN trial: a different dextrose-based solution, icodextrin and amino acids) and followed for 6 months. Combining both studies, 251 patients were allocated to control (n=127) or intervention (n=124) across 11 countries. The primary endpoint was change in glycated hemoglobin from baseline. Mean glycated hemoglobin at baseline was similar in both groups. In the intention-to-treat population, the mean glycated hemoglobin profile improved in the intervention group but remained unchanged in the control group (0.5% difference between groups; 95% confidence interval, 0.1% to 0.8%; P=0.006). Serum triglyceride, very-low-density lipoprotein, and apolipoprotein B levels also improved in the intervention group. Deaths and serious adverse events, including several related to extracellular fluid volume expansion, increased in the intervention group, however. These data suggest that a low-glucose dialysis regimen improves metabolic indices in diabetic patients receiving peritoneal dialysis but may be associated with an increased risk of extracellular fluid volume expansion. Thus, use of glucose-sparing regimens in peritoneal dialysis patients should be accompanied by close monitoring of fluid volume status.
Aim. To investigate the impact of double filtration plasmapheresis (DFPP) and therapeutic plasma exchange (TPE) on hemostasis in renal transplant recipients. Materials and methods. 54 renal transplant patients with an acute humoral rejection were treated with therapeutic apheresis methods: 24 patients with DFPP and 30 patients with TPE. In all patients was performed 3-4 session. We analyzed international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen concentration and platelet count just before and after each session, and after the course of all procedures. After TPE plasma replacement was performed with an equivalent volume of a fresh frozen plasma. After DFPP was performed 10-20% albumin solution. Results and discussion. After each DFPP session was occurred an increased INR and aPTT. After course of all DFPP procedures fibrinogen level decreased by 46%. It was associated with increase of APTT and INR by 35% and 32% respectively. Mainly it was associated with dose of the procedures (volume of plasma perfusion), but not with the plasma separator type. One patient noted hemorrhagic complication. After each TPE session level of fibrinogen concentration, INR and aPPT remained in the normal range, but there was a moderate reduction in platelet count, more pronounced than during DFPP. Hemorrhagic complications were not. Conclusion. Double cascade plasmapheresis and therapeutic plasma exchange generate preconditions for hemorrhagic complications such as increased aPTT and INR, reduce fibrinogen concentration. However, bleeding complications are rare. At the same time, during high volume DFPP should be careful when initially level of fibrinogen is low. In this case fibrinogen concentration should be controlled after the procedure for timely replenishment of its deficit.
Aim:to analyze the results of the regional center for the creation and maintenance of vascular access for hemodialysis.Materials and methods.We performed a retrospective analysis. In five years (2012–2016) we performed 3,837 different operations on vascular access (VA) in 1,862 patients.Results.There is a strong dependence of type VA and the cause of CKD 5D. At the time of the HD start, the proportion of arteriovenous fistula (AVF), synthetic vascular graft (SVG) and central venous catheter (CVC) was 73.7, 0.3 and 26% for glomerulonephritis; 58.4, 0.4 and 41% for pyelonephritis; 53, 1 and 26% for diabetes mellitus; 32, 8 and 60% for polycystic disease and 33, 2 and 65% for systemic processes, respectively. After one year on HD the shares of AVF, SVG and CVC were 89, 2 and 9% for glomerulonephritis; 76, 6 and 18% of pyelonephritis; 70, 5 and 25% for diabetes mellitus; 68, 10 and 22% for polycystic disease and 53, 5 and 42% for systemic processes, respectively. In a case of start of HD via AVF, five years survival was 61% [95% CI 51.8; 71.9]; in a case of start HD via CVC with followed by conversion to AVF – 53.9% [95% CI 42.5; 67]; in a case of CVC remained the only access – 31.6% [21.4; 41.4]. Non-maturation of AVF was observed in 5.9% of new AVF (the risk increased in a case of diabetes mellitus), early thrombosis (before the first use of AVF) was observed in 12.7% of new AVF (the risk increased with diabetes, polycystic and systemic diseases). Creation of AVF a week before the start of HD or 1–2 weeks later significantly increased the risk of thrombosis. Primary patency in a year, three and five years was 77.2% (95% CI 71.7; 81.7); 48% (95% CI 41.6, 54.1); 34.1% (95% CI 27.8, 40.5) respectively; secondary patency – 87% [95% CI 83.7; 89.7]; 74.4% [95% CI 70.3; 78,12]; 60.9% [95% CI 56.4; 65.1] respectively. The use of temporary CVC is associated with a three-fold increase of the risk of infection compared with permanent CVC: IRR 3,31 (2,46; 4,43), p < 0,0001.Conclusion.A more detailed analysis is required to identify risk factors for complications of vascular access and to optimize approaches to its creation and maintenance.
Aim: to analyze the survival of patients on the waiting list for kidney transplantation and the results of transplantation depending on the duration of waiting.Materials and methods. We performed a retrospective observational analysis that included 1,197 patients on the waiting list. The end point was exclusion from the waiting list (WL). The causes for exclusion (death, exclusion due to deterioration of the comorbid background or transplantation) were considered in terms of competing risks.Results. In total, 72.5% of patients reached the end point: 21.1% of them died, 11% were excluded, and 40.4% underwent transplantation. Kaplan–Meier estimate showed that cumulative risk of death was 80.4% [95% CI 77.9; 88.6], of exclusion was 77.9% [95% CI 65.4; 88.2], of transplantation was 63.6% [95% CI 58.3; 69] after 10 years on the waiting list. However, such an assessment cannot be directly interpreted as a prediction of the relevant event risk of occurrence for the patient in the WL, because it does not take into account competing events. According to a balanced assessment of the competing risks (Fine and Gray estimate), cumulative incidence was 30.9% (95% CI 27.7; 34.2) for death, 18.2% [95% CI 15.5; 21.1] for exclusion and 49.4% [95% CI 46; 52.6%] for transplantation after 10 years on WL. The probability of transplantation was significantly higher than the risk of death up to and including 5 years of waiting (incidence rate ratio – IRR 1.769 [95% CI 1.098; 2.897]). When waiting 7 to 8 years, the probability of transplantation was less than the risk of death: IRR 0.25 (95% CI 0.093; 0.588; p = 0.0009). Of the 483 recipients, 61 died and 119 returned to dialysis. The risk of graft loss after 10 years was 68.5% [95% CI 57.5; 79.1] and the risk of death of a recipient with a functioning graft was 48.3% [95% CI 34.7; 63] according to Kaplan–Meier estimate. The cumulative incidence of the method was 30.8% [95% CI 23.3; 38.5%] and 55.7% [95% CI 46.6; 63.5%] according to Fine and Gray estimate, respectively. The risk of death after transplantation increases significantly when waiting for more than 6 years – IRR 4.325 [95% CI 1.649; 10.47], p = 0.0045 relative to a shorter waiting period. With an increase in the waiting period, the comorbid background (CIRS scale) deteriorates significantly, even adjusted for the initial patient condition: the partial correlation r = 0.735; p < 0.0001.Conclusion. 1. In the context of competing risks, the Fine and Gray estimate gives a more balanced risk assessment compared to the Kaplan–Meier method. 2. Increasing the waiting time for transplantation significantly increases the risk of death of the candidate on the waiting list and reduces the probability of transplantation, as well as increases the risk of death of the recipient after transplantation. Apparently, this is mainly due to the deterioration of the comorbid background.
Aim– to perform a comparative study of the long-term results of the combined use of extracorporeal photochemotherapy (photopheresis) and drug immunosuppression and standard immunosuppressive therapy in patients after kidney transplantation.Materials and methods. An open cohort randomized study was conducted, including 60 patients with chronic kidney disease stage 5D. All patients underwent single-group cadaveric kidney transplantation. Patients were randomly divided into two groups. All transplants were paired, the fi rst kidney transplant was received by the patient of the main group, the second – by comparison group. 30 patients of the main group received standard protocol of immunosuppression and 10–15 sessions of photopheresis during the fi rst six months after transplantation. All patients of the comparison group received standard immunosuppressive therapy only. End points: primary – graft loss, surrogate – the number of acute rejection episodes and infectious complications, the dynamics of creatinine blood concentration, the glomerular fi ltration rate and daily proteinuria, the dynamics of tacrolimus C0 blood concentration. To study the mechanism of photopheresis action in the late postoperative period, we evaluated the immunological parameters: subpopulation of naive T-cells (CD3+CD4+CD45RO–CD28+), the level of CD28 molecule expression (MFI) on these cells and also – subpopulation of T-regulatory cells (CD3+CD4+CD25 (Hi)CD127–).Results.The use of photopheresis leads to the graft function improvement in the late postoperative period: the creatinine concentration (p = 0.017) in the blood and daily proteinuria (p = 0.011) were lower in patients of the main group, the glomerular fi ltration rate was higher (p = 0.027). The incidence rate ratio (IRR) of rejection in the main group was signifi cantly lower than in the comparison group: 0.2509 (95% CI 0.05386, 0.9167), p = 0.0358. The risk of graft loss was also lower in the main group: IRR 0.2782 (95% CI 0.07562, 0.8657), p = 0.026, as well as the risk of infectious complications: IRR 0.3888 (95% CI 0.2754; 0, 5445), p < 0.0001. Survival rate of transplants was higher in the main group (Log Rank p = 0.009; Breslow p = 0.005). The use of photopheresis made it possible to reduce the concentration of tacrolimus in the late postoperative period (p = 0.0017) without increasing the risk of graft rejection. The photopheresis tolerogenic effect in the late postoperative period may be due to an increase in the population of T-regulatory cells with the CD3+CD4+CD25(Hi)+CD127– phenotype compared to the patients which received only standard immunosuppressive therapy (p = 0.024).Conclusion.The preventive use of photopheresis contributes to improvement of the kidney transplantation long-term outcomes. Further studies are needed to study the mechanisms of photopheresis action and markers of partial immunological tolerance to the allograft.
Представлен первый отечественный опыт применения трансляционной клеточной иммунотерапии у реципиентов после аллотрансплантации трупной почки. Приведен анализ клинических, лабораторных и иммунологических данных, а также результаты протокольной биопсии трансплантата на 30-е и 180-е сутки после операции. Выявлены клинико-лабораторные, иммунологические и гистологические преимущества у больных основной группы. Установлены некоторые механизмы, раскрывающие возможности формирования иммунологической толерантности. Ключевые слова: аллотрансплантация трупной почки, острое отторжение почечного аллотрансплантата, трансляционная клеточная иммунотерапия, протокольная биопсия почечного аллотрансплантата.
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