scholarly journals Multicenter trial of erythropoietin in patients on peritoneal dialysis.

1995 ◽  
Vol 5 (7) ◽  
pp. 1517-1529
Author(s):  
A R Nissenson ◽  
S Korbet ◽  
M Faber ◽  
J Burkart ◽  
D Gentile ◽  
...  

A randomized, double-blind, placebo-controlled, multicenter trial was performed to assess the safety and efficacy of subcutaneous recombinant erythropoietin (EPO) in peritoneal dialysis patients. Seventy-eight patients were randomized to receive EPO and 74 received placebo during the first 12 wk. After this, placebo patients with hematocrit less than 32% entered the EPO maintenance phase along with the initial EPO patients. Hematocrit rose significantly in the EPO group from 23.8 to 32% after 6 wk, and this was sustained at 33.7% at 12 wk. In the placebo group, the prestudy hematocrit was 23.8% as well, and no significant change in hematocrit occurred over 12 wk. Concomitant with the rise in hematocrit, transfusion requirements fell only in the EPO group. Eighty-eight percent of patients receiving EPO had their anemia ameliorated by Week 12 of the study. There was a wide range of dosage requirements during the maintenance phase, ranging from 8,000 U thrice weekly to 4,000 U every other week. Adverse events after EPO were similar to those seen in hemodialysis patients given this agent, with hypertension developing or worsening in 55% of EPO patients during the initial 12 wk of therapy. Blood pressure was more likely to rise in patients with hypertension before receiving EPO. EPO is safe and effective in peritoneal dialysis patients, as it is in hemodialysis patients. Other than a rise in blood pressure, which is manageable with antihypertensives and ultrafiltration with dialysis, no serious side effects are seen. The optimal target hematocrit, effects of anemia improvement on quality of life, and end-organ (heart, brain) effects of anemia improvement in this patient population require further study.

2021 ◽  
Vol 10 (14) ◽  
pp. 3075
Author(s):  
Claudia Torino ◽  
Rocco Tripepi ◽  
Maria Carmela Versace ◽  
Antonio Vilasi ◽  
Giovanni Tripepi ◽  
...  

Blood pressure changes upon standing reflect a hemodynamic response, which depends on the baroreflex system and euvolemia. Dysautonomia and fluctuations in blood volume are hallmarks in kidney failure requiring replacement therapy. Orthostatic hypotension has been associated with mortality in hemodialysis patients, but neither this relationship nor the impact of changes in blood pressure has been tested in patients on peritoneal dialysis. We investigated both these relationships in a cohort of 137 PD patients. The response to orthostasis was assessed according to a standardized protocol. Twenty-five patients (18%) had systolic orthostatic hypotension, and 17 patients (12%) had diastolic hypotension. The magnitude of systolic and diastolic BP changes was inversely related to the value of the corresponding supine BP component (r = −0.16, p = 0.056 (systolic) and r = −0.25, p = 0.003 (diastolic), respectively). Orthostatic changes in diastolic, but not in systolic, BP were linearly related to the death risk (HR (1 mmHg reduction): 1.04, 95% CI 1.01–1.07, p = 0.006), and this was also true for CV death (HR: 1.08, 95% CI 1.03–1.12, p = 0.001). The strength of this association was not affected by further data adjustment (p ≤ 0.05). These findings suggest that independent of the formal diagnosis of orthostatic hypotension, even minor orthostatic reductions in diastolic BP bear an excess death risk in this population.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.


2020 ◽  
Vol 92 (4) ◽  
pp. 91-97
Author(s):  
A. S. Tokareva ◽  
N. Yu. Borovkova

A present review is devoted to the current state of the problem of blood pressure variability (BPV) in hemodialysis patients. The BPV classification and clinical significance of BPV metrics are discussed. The results of cohort and randomized studies on the high BPV influence on outcomes in hemodialysis patients, as well as on the possibilities of antihypertensive drugs in the treatment of high BPV in dialysis patients, are presented.


2006 ◽  
Vol 134 (3-4) ◽  
pp. 133-137 ◽  
Author(s):  
Mirjana Lausevic ◽  
Vidosava Nesic ◽  
Natasa Jovanovic ◽  
Biljana Stojimirovic

A normocytic normochromic anemia is one of the first signs of renal failure. Since anemia increases morbidity and mortality, its elimination is one of the essential objectives of the treatment. Human recombinant erythropoietin (rHuEPO) has changed the therapeutical approach to anemia. The aim of the present study was to compare efficacy of anemia correction in peritoneal dialysis patients depending on treatment and dialysis modality. The study is the retrospective analysis of 64 patients who presented to our Clinic in 2003. Eighteen (28.13%) patients were treated with rHuEPO, 14 (28%) underwent continuous ambulatory peritoneal dialysis (CAPD), 2 (100%) - automated peritoneal dialysis (APD) and 2 (33.3%) - intermittent peritoneal dialysis (IPD). Mean hemoglobin level was 98.6?17.82 g/l in patients treated with rHuEPO versus 98.81?15.14 g/I in patients without rHuEPO treatment. Erythropoietin requirements were 3392.85?1211.77 IU/week. AII patients received iron supplementation during rHuEPO therapy. Mean serum ferritin levels were 463.41 ?360 ?g/l. Transferrin saturation (TSAT) was 0.35?0.16%. No difference of serum iron and TSAT levels was found between CAPD and IPD patients. The degree of anemia significantly differed between CAPD and IPD patients. A total of 17.11% of PD patients were given blood transfusions, most frequently during the first three months after the onset of dialysis. Our conclusion is that the number of patients receiving rHuEPO should be increased, as 50% of our patients should be substituted, while only 28% are being treated. As 50% of patients receiving rHuEPO failed to reach target Hgb levels, higher EPO doses should be considered. Iron stores should be continuously monitored, particularly in patients receiving rHuEPO, since iron deficiency is an important problem for patients undergoing peritoneal dialysis, especially during erythropoietin therapy. Oral iron supplementation is satisfactory in the majority of patients, and iron-gluconate is absorbed better than iron-sulphate. If required, intra-venous iron bolus is safe and efficient. Continuous peritoneal dialysis treatment improves blood count more effectively compared to intermittent procedures, as hemoglobin levels are significantly higher in patients with comparable iron stores. Peritoneal dialysis is particularly efficient in improving the blood count in diabetics, since no significant difference of anemia between patients affected by diabetes mellitus and the others could be found in our study.


2019 ◽  
Vol 32 (10) ◽  
pp. 992-1002
Author(s):  
Eun Joo Cho ◽  
Hae Young Lee ◽  
Ki Chul Sung ◽  
Sungha Park ◽  
Il-Suk Sohn ◽  
...  

Abstract OBJECTIVE The main objective of this study was to evaluate non-inferiority of office mean systolic blood pressure (BP) reduction efficacy and superiority of 24-hour ambulatory central BP reduction efficacy between losartan combined with fixed dose amlodipine (L/A group) and dose up-titrated hydrochlorothiazide (L/H group) according to office BP. METHODS We conducted a prospective, randomized, double-blind multicenter trial in 231 patients with hypertensive (mean age = 59.2 ± 12.2 years). Patients received losartan 50 mg monotherapy for 4 weeks, followed by additional use of amlodipine 5 mg or hydrochlorothiazide 12.5 mg for 20 weeks after randomization. The patients who did not achieve the BP goal after 4 weeks’ randomization received an increased dose of 100 mg/5 mg for the L/A group and 100 mg/25 mg for L/H group, respectively. The 24-hour ambulatory central BP was measured at baseline and after 20 weeks’ treatment. RESULTS Office mean systolic BP reduction of L/A group was not inferior to L/H group after 4 weeks’ treatment (–17.6 ± 13.3 vs. –14.4 ± 12.6 mm Hg, P = 0.0863) and was not significantly different after 20 weeks’ treatment. (–15.7 ± 14.0 vs. –14.7 ± 15.1 mm Hg, P = 0.6130) The 24-hour ambulatory central systolic BP was significantly more reduced in the L/A group compared with that in the L/H group after 20 weeks’ treatment (–9.37 ± 10.67 vs. –6.28 ± 10.50 mm Hg, P = 0.0407). The 24-hour ambulatory central systolic BP at the completion of the study and its reduction magnitude were independently associated with reductions in aortic pulse wave velocity, pulse pressure, and wave reflection magnitude. CONCLUSION Office systolic BP reduction with L/A was not inferior to L/H after 4 week’s treatment. The combination of losartan and amlodipine was more favorable in 24-hour ambulatory central hemodynamics beyond BP-lowering efficacy than the combination of losartan and hydrochlorothiazide, regardless of office BP. CLINICAL TRIALS REGISTRATION NCT02294539


2002 ◽  
Vol 22 (3) ◽  
pp. 371-379 ◽  
Author(s):  
◽  
Michael V. Rocco ◽  
Diane L. Frankenfield ◽  
Barbara Prowant ◽  
Pamela Frederick ◽  
...  

Background Potential risk factors for 1-year mortality, including the peritoneal component of dialysis dose, residual renal function, demographic data, hematocrit, serum albumin, dialysate-to-plasma creatinine ratio, and blood pressure, were examined in a national cohort of peritoneal dialysis patients randomly selected for the Centers for Medicare and Medicaid Services End-Stage Renal Disease (ESRD) Core Indicators Project. Methods The study involved retrospective analysis of a cohort of 1219 patients receiving chronic peritoneal dialysis who were alive on December 31, 1996. Results During the 1-year follow-up period, 275 patients were censored and 200 non censored patients died. Among the 763 patients who had at least one calculable adequacy measure, the mean [± standard deviation (SD)] weekly Kt/V urea was 2.16 ± 0.61 and the mean weekly creatinine clearance was 66.1 ± 24.4 L/1.73 m2. Excluding the 365 patients who were anuric, the mean (±SD) urinary weekly Kt/V urea was 0.64 ± 0.52 (median: 0.51) and the mean (±SD) urinary weekly creatinine clearance was 31.0 ± 23.3 L/1.73 m2 (median: 26.3 L/1.73 m2). By Cox proportional hazard modeling, lower quartiles of renal Kt/V urea were predictive of 1-year mortality; lower quartiles of renal creatinine clearance were of borderline significance for predicting 1-year mortality. The dialysate component of neither the weekly creatinine clearance nor the weekly Kt/V urea were predictive of 1-year mortality. Other predictors of 1-year mortality ( p < 0.01) included lower serum albumin level, older age, and the presence of diabetes mellitus as the cause of ESRD, and, for the creatinine clearance model only, lower diastolic blood pressure. Conclusion Residual renal function is an important predictor of 1-year mortality in chronic peritoneal dialysis patients.


1990 ◽  
Vol 10 (4) ◽  
pp. 275-278 ◽  
Author(s):  
Anne s. Lindblad ◽  
Karl D. Nolph

A survey of the National CAPD Registry population was conducted to assess the distribution of hematocrit levels in a large group of peritoneal dialysis patients, to characterize the anemia of the population, and identify factors which relate to variation in hematocrit levels. A random sample of 812 patients was selected from the Registry population. Information was provided on 608 patients. Characteristics of sampled patients were similar to the Registry population as a whole. The mean hematocrit level in this cohort was 29.4% and the median was 29%. Recent peritonitis, time on CAPD, folate therapy, androgen therapy, and iron therapy had no obvious influence on hematocrit distributions. Significantly higher hematocrits were seen in males, whites, and patients with polycystic kidney disease. Significantly lower hematocrits were seen in surgically anephric patients and in patients who had received transfusions 60 days before the survey. Eighty-nine percent of patients had not received a transfusion 60 days prior to the survey. Some patients, especially those with hematocrits below the median, might benefit from recombinant erythropoietin therapy.


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