scholarly journals Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): Study Protocol for a Randomized Controlled Crossover Trial

2020 ◽  
Author(s):  
Karin Bergling ◽  
Javier de Arteaga ◽  
Fabián Ledesma ◽  
Carl Mikael Öberg
Keyword(s):  
Peritoneal Dialysis ◽  
Clinical Investigation ◽  
Glucose Absorption ◽  
Treatment Session ◽  
Crossover Fashion ◽  
Diabetic Patients ◽  
Automated Peritoneal Dialysis ◽  
Open Label ◽  
Sodium Removal ◽  
Before And After

Abstract 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 to 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 hours) or Optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 hours). 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: 12/07/2019, retrospectively registered. URL: https://clinicaltrials.gov/ct2/show/NCT04017572

scholarly journals Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): Study Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Karin Bergling ◽  
Javier de Arteaga ◽  
Fabián Ledesma ◽  
Carl Mikael Öberg
Keyword(s):  
Peritoneal Dialysis ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
Glucose Absorption ◽  
Treatment Session ◽  
Crossover Fashion ◽  
Diabetic Patients ◽  
Automated Peritoneal Dialysis ◽  
Open Label ◽  
Before And After

Abstract 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 to 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 hours) or Optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 hours). 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.

Sodium Removal in Patients Undergoing CAPD and Automated Peritoneal Dialysis

2002 ◽  
Vol 22 (6) ◽  
pp. 705-713 ◽  
Author(s):  
Ana Rodríguez–Carmona ◽  
Miguel Pérez Fontán
Keyword(s):  
Peritoneal Dialysis ◽  
Automated Peritoneal Dialysis ◽  
Cross Sectional Survey ◽  
Removal Rates ◽  
Cross Sectional ◽  
Sodium Removal ◽  
Before And After ◽  
Main Factors ◽  
The Impact ◽  
Residual Diuresis

Objectives To compare sodium removal in continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) patients, and to identify the main factors that modify Na removal in clinical practice in these patients. Design Study in three steps. Cross-sectional observational (Study A), and longitudinal interventional (Studies B and C). Patients and Methods First (Study A) we carried out a cross-sectional survey of Na removal in 63 patients on CAPD and 78 patients on APD. Second (Study B), we studied Na removal in 32 patients before and after changing from CAPD to APD therapy. Finally (Study C), we analyzed the impact on Na removal of introducing icodextrin for the long dwell in 16 patients undergoing CAPD or APD. Results In Study A, total Na removal averaged 210 mmol/day for CAPD patients and 91 mmol/day for APD patients ( p < 0.001); Na removal was < 100 mmol/day in 7.1% of CAPD patients and 56.4% of APD patients. Multivariate analysis identified ultrafiltration [B = 125 mmol/day, 95% confidence interval (CI) 110, 140], CAPD therapy (B = 60 mmol/day, 95%CI 37, 83), and residual diuresis (B = 51 mmol/L, 95%CI 34, 69) as independent predictors of Na removal (adjusted r2 = 0.76). For APD patients, longer nocturnal dwell times and performing a supplementary diurnal exchange were also independently associated with higher Na removal rates. In Study B, Na removal decreased from 192 to 92 mmol/day (median) after the change to APD ( p = 0.02). In Study C, peritoneal Na removal increased from 98 to 148 mmol/day (median) ( p = 0.04) after introducing icodextrin. Conclusions Standard APD schedules are frequently associated with poor Na removal rates. For any degree of ultrafiltration, Na removal is better in CAPD than in APD. Icodextrin, supplementary diurnal exchanges, and longer nocturnal dwell times improve Na removal in APD. Sodium removal can be estimated from ultrafiltration in patients on CAPD, but must be specifically monitored in patients on APD.

Peritoneal Solute Clearances after four Years of Continuous Ambulatory Peritoneal Dialysis (CAPD)

1989 ◽  
Vol 9 (1) ◽  
pp. 75-78 ◽  
Author(s):  
Min Sun Park ◽  
Jean Lee ◽  
Moon Sung Lee ◽  
Seung Ho Baick ◽  
Seung Duk Hwang ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Glucose Absorption ◽  
Peritoneal Membrane ◽  
Vasoactive Agents ◽  
Membrane Function ◽  
Dialysis Solution ◽  
Before And After ◽  
Dialysate Volume

In order to evaluate peritoneal membrane function and responsiveness of peritoneal microcirculation to vasoactive agents in long-term continuous ambulatory peritoneal dialysis (CAPD) patients, we studied peritoneal clearances of urea (Curea) and creatinine (Ccr), protein concentrations in drained dialysate (D PC), peritoneal glucose absorption (% GA), and drained dialysate volume ( VD) before and after nitroprusside (NP) addition to dialysis solution in 17 long-term CAPD patients (mean duration of CAPD: 52 months) and the results were compared to those of 18 patients who were just trained for CAPD (mean duration: 0.6 month). There were no differences in the control (without NP) Curea, Ccr, D PC, %GA, and VD between the new and long-term CAPD patients. Curea, Ccr, and D PC increased significantly with NP in both new and long-term patients. Curea and Ccr with NP were not different between the new and long-term patients but D PC with NP was significantly lower in the long-term CAPD patients. The results of this study suggest that peritoneal solute clearances and the responsiveness of peritoneal microcirculation to NP remain unchanged after four years of CAPD, despite recurrent episodes of peritonitis.

scholarly journals Peritoneal Water Transport Characteristics of Diabetic Patients Undergoing Peritoneal Dialysis: A Longitudinal Study

2017 ◽  
Vol 46 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Ana Fernandes ◽  
Roi Ribera-Sanchez ◽  
Ana Rodríguez-Carmona ◽  
Antía López-Iglesias ◽  
Natacha Leite-Costa ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Water Transport ◽  
Free Water ◽  
Volume Overload ◽  
Diabetic Patients ◽  
Longitudinal Analyses ◽  
Cross Sectional ◽  
Sodium Removal ◽  
Essential Stability ◽  
Stability Of Water

Background: Volume overload is frequent in diabetics undergoing peritoneal dialysis (PD), and may play a significant role in the excess mortality observed in these patients. The characteristics of peritoneal water transport in this population have not been studied sufficiently. Method: Following a prospective, single-center design we made cross-sectional and longitudinal comparisons of peritoneal water transport in 2 relatively large samples of diabetic and nondiabetic PD patients. We used 3.86/4.25% glucose-based peritoneal equilibration tests (PET) with complete drainage at 60 min, for these purposes. Main Results: We scrutinized 59 diabetic and 120 nondiabetic PD patients. Both samples showed relatively similar characteristics, although diabetics were significantly more overhydrated than nondiabetics. The baseline PET disclosed lower ultrafiltration (mean 439 mL diabetics vs. 532 mL nondiabetics, p = 0.033) and sodium removal (41 vs. 53 mM, p = 0.014) rates in diabetics. One hundred and nine patients (36 diabetics) underwent a second PET after 12 months, and 45 (14 diabetics) underwent a third one after 24 months. Longitudinal analyses disclosed an essential stability of water transport in both groups, although nondiabetic patients showed a trend where an increase in free water transport (p = 0.033) was observed, which was not the case in diabetics. Conclusions: Diabetic patients undergoing PD present lower capacities of ultrafiltration and sodium removal than their nondiabetic counterparts. Longitudinal analyses disclose an essential stability of water transport capacities, both in diabetics and nondiabetics. The clinical significance of these differences deserves further analysis.

scholarly journals Modulation of gut microbiota dysbioses in type 2 diabetic patients by macrobiotic Ma-Pi 2 diet

2016 ◽  
Vol 116 (1) ◽  
pp. 80-93 ◽  
Author(s):  
Marco Candela ◽  
Elena Biagi ◽  
Matteo Soverini ◽  
Clarissa Consolandi ◽  
Sara Quercia ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Metabolic Control ◽  
Gut Microbiome ◽  
Control Diet ◽  
Normal Weight ◽  
Diabetic Patients ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Before And After

AbstractThe gut microbiota exerts a role in type 2 diabetes (T2D), and deviations from a mutualistic ecosystem layout are considered a key environmental factor contributing to the disease. Thus, the possibility of improving metabolic control in T2D by correcting gut microbiome dysbioses through diet has been evaluated. Here, we explore the potential of two different energy-restricted dietary approaches – the fibre-rich macrobiotic Ma-Pi 2 diet or a control diet recommended by Italian professional societies for T2D treatment – to correct gut microbiota dysbioses in T2D patients. In a previous 21-d open-label MADIAB trial, fifty-six overweight T2D patients were randomised to the Ma-Pi 2 or the control diet. For the present study, stools were collected before and after intervention from a subset of forty MADIAB participants, allowing us to characterise the gut microbiota by 16S rRNA sequencing and imputed metagenomics. To highlight microbiota dysbioses in T2D, the gut microbiota of thirteen normal-weight healthy controls were characterised. According to our findings, both diets were effective in modulating gut microbiome dysbioses in T2D, resulting in an increase of the ecosystem diversity and supporting the recovery of a balanced community of health-promoting SCFA producers, such asFaecalibacterium,Roseburia,Lachnospira,BacteroidesandAkkermansia. The Ma-Pi 2 diet, but not the control diet, was also effective in counteracting the increase of possible pro-inflammatory groups, such asCollinsellaandStreptococcus, in the gut ecosystem, showing the potential to reverse pro-inflammatory dysbioses in T2D, and possibly explaining the greater efficacy in improving the metabolic control.

scholarly journals Policy changes and impact rises: Erythropoietin Payment Policy on Cardiovascular Outcomes of Peritoneal Dialysis Patients

2020 ◽  
Author(s):  
I-Chun Lai ◽  
Ying-Hui Hou ◽  
Shih-Pi Lin ◽  
Thomas T.H. Wan ◽  
Feng-Jung Yang ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Cardiovascular Risk ◽  
Cardiovascular Events ◽  
Propensity Scores ◽  
Cardiovascular Outcomes ◽  
Diabetic Patients ◽  
Cardiovascular Risks ◽  
Before And After ◽  
Cardiovascular Endpoint ◽  
The Impact

Abstract Background and Purposes The change in reimbursement policy of erythropoietin application to peritoneal dialysis (PD) patients by Taiwan National Health Insurance (NHI) system provided a natural experimental venue to examine whether cardiovascular risk differs while keeping hematocrit (Hct) below 30% or over 30%. This study intended to analyze the impact of loosening erythropoietin payment criteria for PD patients on their cardiovascular outcomes. Methods Two cohorts of incident PD patients before and after the relaxation of NHI’s erythropoietin payment criteria were identified as Cohort 1 and Cohort 2, respectively, and further matched by propensity scores and then followed up for cardiovascular events. There were 1,759 patients in Cohort 1 and 2,981 patients in Cohort 2. After propensity score matching, 1,754 subjects were selected from each cohort. The outcome measures were cardiovascular events and were analyzed through Cox regressions. Findings and Conclusion For the composite cardiovascular endpoint, Cohort 2 patients had significantly lower risk than Cohort 1. The risk reduction was observed only in diabetic patients. After loosening erythropoietin payment criteria, less cardiovascular risks were observed, particularly for diabetic patients. It is concluded that for diabetic PD patients, maintaining a Hct level higher than 30% is crucial for reducing the cardiovascular risk.

Patient Selection for Automated Peritoneal Dialysis: For Whom, When?

2009 ◽  
Vol 29 (2_suppl) ◽  
pp. 102-107 ◽  
Author(s):  
Vassilios Liakopoulos ◽  
Nicholas Dombros
Keyword(s):  
Peritoneal Dialysis ◽  
Residual Renal Function ◽  
Patient Choice ◽  
Rapid Decline ◽  
Automated Peritoneal Dialysis ◽  
Contributing Factors ◽  
Dialysis Dose ◽  
Intraperitoneal Pressure ◽  
Sodium Removal ◽  
Disturbed Sleep

The use of the various forms of automated peritoneal dialysis (APD) has increased considerably in the past few years. This increase has in part been driven by technology, through improved cycler design. Other contributing factors include better adjustment of APD to patient lifestyle, the flexibility that APD offers to patients, and the increased ability of APD to achieve adequacy and ultrafiltration targets. For high transporters and for patients unable to perform peritoneal dialysis (PD) on their own (for example, pediatric and elderly patients), APD is considered the most suitable PD modality. Furthermore, APD has been associated with improved compliance, lower intraperitoneal pressure, and lower incidences of peritonitis. On the other hand, concerns have been raised regarding increased complexity and cost, a more rapid decline in residual renal function, inadequate sodium removal, and disturbed sleep. Automated PD is an alternative to continuous ambulatory PD when a higher dialysis dose is needed, and it could be a reliable alternative for unplanned or urgent dialysis start. Other than beneficial results in high transporters, the medical advantages of APD remain controversial. Individual patient choice therefore remains the main indication for the application of APD, which should be made available to all patients starting PD.

Peritoneal Solute Clearances in Diabetics

1990 ◽  
Vol 10 (1) ◽  
pp. 85-88 ◽  
Author(s):  
Hi Bahl Lee ◽  
Min Sun Park ◽  
Sung Hee Chung ◽  
Young Bae Lee ◽  
Kyung Soo Kim ◽  
...  
Keyword(s):  
Body Weight ◽  
Peritoneal Dialysis ◽  
Solute Transport ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Vascular Diseases ◽  
Glucose Absorption ◽  
Peritoneal Membrane ◽  
Before And After ◽  
Esrd Patients

In order to examine solute transport across the peritoneal membrane and responsiveness of the peritoneal microcirculation to a vasodilator in diabetics on continuous ambulatory peritoneal dialysis (CAPD), we obtained peritoneal clearances of urea (Curea) and creatinine (Ccr), protein concentrations in the drained dialysate (D PC), and percentage of peritoneal glucose absorption (% PGA) before and after nitroprusside (NP) addition to the dialysate in 13 diabetics (DM) and 13 nondiabetics (non-DM) matched for age, sex, body weight, and duration of CAPD. Control (before NP) Curea, Ccr, D PC, and %PGA were not different between DM and non-DM. NP significantly enhanced Curea, Ccr, and D PC in both DM and non-DM. Curea, Ccr, D PC, and %PGA after NP were again not different between DM and non-DM. The findings suggest that peritoneal solute clearances and responsiveness of the peritoneal microcirculation to NP in diabetics are not different from nondiabetics at the beginning of CAPD despite evidence for widespread vascular diseases in diabetic ESRD patients.

Automated Peritoneal Dialysis: An alternative to Continuous Ambulatory or a First Choice Treatment?

2014 ◽  
Vol 12 (2) ◽  
pp. 77-83
Author(s):  
Evangelia Dounousi ◽  
Anila Duni ◽  
Konstantinos Leivaditis ◽  
Vassilios Liakopoulos
Keyword(s):  
Peritoneal Dialysis ◽  
Residual Renal Function ◽  
Rapid Decline ◽  
Automated Peritoneal Dialysis ◽  
Intraperitoneal Pressure ◽  
The Past ◽  
Sodium Removal ◽  
Disturbed Sleep ◽  
First Choice ◽  
Important Indication

Abstract The use of the various forms of Automated Peritoneal Dialysis (APD) has considerably increased in the past few years. This increase is driven by improved cycler design, apparent lifestyle advantages, and the increased ability to achieve adequacy and ultrafiltration targets. It is therefore reasonable to raise the question whether APD is superior to Continuous Ambulatory Peritoneal Dialysis (CAPD). APD is considered the most suitable Peritoneal Dialysis (PD) modality for high transporters as well as for assisted PD. It has also been associated with improved compliance, lower intraperitoneal pressure and possibly lower incidence of peritonitis. On the other hand, there are concerns regarding increased cost, a more rapid decline in residual renal function, inadequate sodium removal and disturbed sleep. Besides its beneficial results in high transporters, other medical advantages of APD still remain unclear. Individual patient’s choice remains the most important indication for applying APD, which should be made available to all patients starting PD.

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