Factors Influencing Telehealth Service Use and Health Outcomes in Patients Undergoing Continuous Ambulatory Peritoneal Dialysis: Cross-Sectional Study.

BACKGROUND: Several studies have demonstrated the efficacy and user acceptance of telehealth in managing patients with chronic conditions, including continuous ambulatory peritoneal dialysis (CAPD). However, the rates of telehealth service use in various patient groups have been low and have declined over time, which may affect important health outcomes. Telehealth service use in patients undergoing CAPD has been recognized as a key challenge that needs to be examined further. OBJECTIVE: This study aimed to explore the rates of telehealth service use over 4 months, identify factors influencing its use, and examine the relationship between telehealth service use and health outcomes in Thai people undergoing CAPD. METHODS: This cross-sectional study, which was a part of a pragmatic randomized controlled trial study, was conducted at a dialysis center in Bangkok, Thailand. The study included patients who were undergoing CAPD. These patients were randomly enrolled in the intervention group to receive telehealth service and additional standard care for 4 months. Data were collected using self-reported questionnaires, including a demographic form, Functional, Communicative, and Critical Health Literacy Scale, Perceived Usefulness Questionnaire, Brief Illness Perception Questionnaire, Patient-Doctor Relationship Questionnaire, and Kidney Disease Quality of Life 36 Questionnaire. Additionally, Google Analytics was used to obtain data on the actual use of the telehealth service. These data were analyzed using descriptive statistics, repeated-measures ANOVA, and regression analyses. RESULTS: A total of 159 patients were included in this study. The mean rate of telehealth service use throughout the period of 4 months was 62.06 (SD 49.71) times. The rate of telehealth service use was the highest in the first month (mean 23.48, SD 16.28 times) and the lowest in the third month (mean 11.09, SD 11.48 times). Independent variables explained 27.6% of the sample variances in telehealth service use. Older age (ß=.221; P=.002), higher perceived usefulness (ß=.414; P<.001), unemployment (ß=-.155; P=.03), and positive illness perception (ß=-.205; P=.004) were associated with a significantly higher rate of telehealth service use. Regarding the relationship between telehealth service use and health outcomes, higher rates of telehealth service use were linked to better quality of life (ß=.241; P=.002) and lower peritonitis (odds ratio 0.980, 95% CI 0.962-0.997; P=.03). CONCLUSIONS: This study provides valuable insights into factors impacting telehealth service use, which in turn affect health outcomes in patients undergoing CAPD.

Enhancing healthcare quality and outcomes for peritoneal dialysis patients in Thailand: An evaluation of key performance indicators and PDOPPS cohort representativeness.

AIM: To assess whether the peritoneal dialysis (PD) centres included in the Peritoneal Dialysis Outcomes and Practise Patterns Study (PDOPPS) in Thailand are representative of other PD centres in the country, based on 8 key performance indicators (KPIs 1-8). METHODS: A retrospective analysis was conducted comparing PD-related clinical outcomes between PD centres included in the PDOPPS (the PDOPPS group) and those not included (the non-PDOPPS group) from January 2018 to December 2019. Logistic regression analysis was used to identify predictors associated with achieving the target KPIs. RESULTS: Of 181 PD centres, 22 (12%) were included in the PDOPPS. PD centres in the PDOPPS group were larger and tended to serve more PD patients than those in the non-PDOPPS group. However, the process and outcome KPIs (KPIs 1-8) were comparable between the 2 groups. Large hospitals (≥120 beds), providing care to ≥100 PD cases and having experience for >10 years were independent predictors of achieving the peritonitis rate target of <0.5 episodes/year. Most PD centres in Thailand showed weaknesses in off-target haemoglobin levels and culture-negative peritonitis rate. CONCLUSIONS: The PD centres included in Thai PDOPPS were found to be representative of other PD centres in Thailand in terms of clinical outcomes. Thus, Thai PDOPPS findings may apply to the broader PD population in Thailand.

Fatality rate, risk factors, and functional decline in peritoneal dialysis patients with coronavirus disease 2019: A nationwide cohort study.

Background: The fatality rates and factors associated with death from coronavirus disease 2019 (COVID-19) in hemodialysis patients have been extensively investigated. However, data on peritoneal dialysis (PD) patients remain scarce. Materials and methods: In this nationwide cohort study, we assessed the 28-day COVID-19-related fatality rate in PD patients between August 2021 and July 2022 using data from the InCov19-PD registry. Predictors associated with death were evaluated using a multivariable Cox regression model. Changes in functional status before and during COVID-19 were also examined. Results: A total of 1,487 eligible participants were evaluated. During the study period, 196 participants died within 28 days after COVID-19 diagnosis (case fatality rate: 13%). In a multivariable Cox regression model, an increased risk of death within 28 days after COVID-19 diagnosis among PD patients was independently associated with functional impairment during COVID-19 [adjusted hazard ratio (HR) 2.46, 95% confidence interval (CI) 1.59-3.81], SARS-CoV-2 infection with the Delta variant (HR 2.23, 95% CI 1.55-3.21), and the need for respiratory support (HR 7.13, 95% CI 3.74-13.57) (p < 0.01 for all). Conversely, the number of COVID-19 vaccines administered (HR 0.69, 95% CI 0.55-0.87; p = 0.001) and receiving corticosteroid therapy during COVID-19 (HR 0.72, 95% CI 0.54-0.97; p = 0.03) were associated with a decreased risk of death within 28 days after COVID-19 diagnosis. The number of functionally independent PD patients dropped from 94% at baseline to 63% during COVID-19 (p < 0.01). Conclusions: The COVID-19-related 28-day fatality rate was high among PD patients. The predictors of COVID-19-related death in PD patients were similar to those in hemodialysis patients. During COVID-19, PD patients commonly experienced functional deterioration.

Durability of Humoral and Cellular Immunity after an Extended Primary Series with Heterologous Inactivated SARS-CoV-2 Prime-Boost and ChAdOx1 nCoV-19 in Dialysis Patients (ICON3).

The durability of a three-dose extended primary series of COVID-19 vaccine in dialysis patients remains unknown. Here, we assessed dynamic changes in SARS-CoV-2-specific humoral and cell-mediated immunity at baseline, 3 months, and 6 months after the extended primary series in 29 hemodialyzed (HD), 28 peritoneal dialyzed (PD) patients, and 14 healthy controls. Participants received two doses of inactivated SARS-CoV-2 vaccine followed by a dose of ChAdOx1 nCoV-19 vaccine. At 6 months, median anti-RBD IgG titers (IQR) significantly declined from baseline in the HD (1741 (1136−3083) BAU/mL vs. 373 (188−607) BAU/mL) and PD (1093 (617−1911) BAU/mL vs. 180 (126−320) BAU/mL) groups, as did the mean percent inhibition of neutralizing antibodies (HD: 96% vs. 81%; PD: 95% vs. 73%) (all p < 0.01). Age and post-vaccination serological response intensity were predictors of early humoral seroprotection loss. In contrast, cell-mediated immunity remained unchanged. In conclusion, humoral immunity declined substantially in dialysis patients, while cell-mediated immunity remained stable 6 months after the extended heterologous primary series of two inactivated SARS-CoV-2/ChAdOx1 nCoV-19 vaccine. A booster dose could be considered in dialysis patients 3 months after this unique regimen, particularly in the elderly or those with a modest initial humoral response.

Predictors and outcomes of peritoneal dialysis-related infections due to filamentous molds (MycoPDICS).

INTRODUCTION: We sought to evaluate the predictors and outcomes of mold peritonitis in patients with peritoneal dialysis (PD). METHODS: This cohort study included PD patients from the MycoPDICS database who had fungal peritonitis between July 2015-June 2020. Patient outcomes were analyzed by Kaplan Meier curves and the Log-rank test. Multivariable Cox proportional hazards model regression was used to estimating associations between fungal types and patients' outcomes. RESULTS: The study included 304 fungal peritonitis episodes (yeasts n = 129, hyaline molds n = 122, non-hyaline molds n = 44, and mixed fungi n = 9) in 303 patients. Fungal infections were common during the wet season (p <0.001). Mold peritonitis was significantly more frequent in patients with higher hemoglobin levels, presentations with catheter problems, and positive galactomannan (a fungal cell wall component) tests. Patient survival rates were lowest for non-hyaline mold peritonitis. A higher hazard of death was significantly associated with leaving the catheter in-situ (adjusted hazard ratio [HR] = 6.15, 95%confidence interval [CI]: 2.86-13.23) or delaying catheter removal after the diagnosis of fungal peritonitis (HR = 1.56, 95%CI: 1.00-2.44), as well as not receiving antifungal treatment (HR = 2.23, 95%CI: 1.25-4.01) or receiving it for less than 2 weeks (HR = 2.13, 95%CI: 1.33-3.43). Each additional day of antifungal therapy beyond the minimum 14-day duration was associated with a 2% lower risk of death (HR = 0.98, 95%CI: 0.95-0.999). CONCLUSION: Non-hyaline-mold peritonitis had worse survival. Longer duration and higher daily dosage of antifungal treatment were associated with better survival. Deviations from the 2016 ISPD Peritonitis Guideline recommendations concerning treatment duration and catheter removal timing were independently associated with higher mortality.

Efficacy of Potassium Supplementation in Hypokalemic Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Hypokalemia is a common electrolyte abnormality in patients on peritoneal dialysis (PD) and has been associated with increased risks of peritonitis and death. Whether correction of hypokalemia improves these outcomes is unknown. STUDY DESIGN: Multicenter, open-label, prospective, randomized controlled trial. SETTING & PARTICIPANTS: Adult (aged ≥18 years) PD patients with hypokalemia (defined as at least 3 values or an average value <3.5 mEq/L in the past 6 months). Randomization was stratified according to center and residual urine output (≤100 or >100 mL/day). INTERVENTIONS: Random assignment to either protocol-based potassium supplementation (titratable dose of oral potassium chloride to maintain serum potassium of 4-5 mEq/L) or conventional potassium supplementation (reactive supplementation when serum potassium is <3.5 mEq/L) over 52 weeks. Treatment groups were compared using intention-to-treat analyses implemented using Cox proportional hazards regression. OUTCOME: The primary outcome was time from randomization to first peritonitis episode (any organism). Secondary outcomes were all-cause mortality, cardiovascular mortality, hospitalization, and conversion to hemodialysis. RESULTS: A total of 167 patients with time-averaged serum potassium concentrations of 3.33 ± 0.28 mEq/L were enrolled from 6 PD centers: 85 were assigned to receive protocol-based treatment, and 82 were assigned to conventional treatment. The median follow-up time was 401 (IQR, 315-417) days. During the study period, serum potassium levels in the protocol-based treatment group increased to 4.36 ± 0.70 mEq/L compared with 3.57 ± 0.65 mEq/L in the group treated conventionally (mean difference, 0.66 [95% CI, 0.53-0.79] mEq/L; P < 0.001). The median time to first peritonitis episode was significantly longer in the protocol-based group (223 [IQR, 147-247] vs 133 [IQR, 41-197] days, P = 0.03). Compared with conventional treatment, the protocol-based group had a significantly lower hazard of peritonitis (HR, 0.47 [95% CI, 0.24-0.93]) but did not differ significantly with respect to any of the secondary outcomes. Asymptomatic hyperkalemia (>6 mEq/L) without characteristic electrocardiographic changes occurred in 3 patients (4%) in the protocol-based treatment group. LIMITATIONS: Not double-masked. CONCLUSIONS: Compared with reactive potassium supplementation when the serum potassium level falls below 3.5 mEq/L, protocol-based oral potassium treatment to maintain a serum potassium concentration in the range of 4-5 mEq/L may reduce the risk of peritonitis in patients receiving PD who have hypokalemia. TRIAL REGISTRATION: Registered at the Thai Clinical Trials Registry with study number TCTR20190725004.

Immunogenicity of ChAdOx1 nCoV-19 vaccine after a two-dose inactivated SARS-CoV-2 vaccination of dialysis patients and kidney transplant recipients.

Vaccination with inactivated SARS-CoV-2 virus produces suboptimal immune responses among kidney transplant (KT), peritoneal dialyzed (PD), and hemodialyzed (HD) patients. Participants were vaccinated with two-dose inactivated SARS-CoV-2 vaccine (V2) and a third dose of ChAdOx1 nCoV-19 vaccine (V3) at 1-2 months after V2. We enrolled 106 participants: 31 KT, 28 PD, and 31 HD patients and 16 controls. Among KT, PD, and HD groups, median (IQR) of anti-receptor binding domain antibody levels were 1.0 (0.4-26.8), 1092.5 (606.9-1927.2), and 1740.9 (1106-3762.3) BAU/mL, and percent neutralization was 0.9 (0-9.9), 98.8 (95.9-99.5), and 99.4 (98.8-99.7), respectively, at two weeks after V3. Both parameters were significantly increased from V2 across all groups (p < 0.05). Seroconversion and neutralization positivity rates in PD, HD, and control groups were 100% but were impaired in KT patients (39% and 16%, respectively). S1-specific T-cell counts were increased in PD and HD groups (p < 0.05) but not in KT patients. The positive S1-specific T-cell responder rate was > 90% in PD, HD, and control groups, which was higher than that in KT recipients (74%, p < 0.05). The heterologous inactivated virus/ChAdOx1 nCoV-19 vaccination strategy elicited greater immunogenicity among dialysis patients; however, inadequate responses remained among KT recipients (TCTR20210226002).

Association analysis of body composition with survival among prevalent peritoneal dialysis patients.

PURPOSE: Progressive decline in lean mass and gain of fat mass are common in patients treated with peritoneal dialysis (PD). It is unclear whether body composition or its longitudinal changes contribute to increased mortality among prevalent PD patients. METHODS: This was a retrospective cohort study. Body composition was assessed using bioelectrical impedance spectroscopy (BIS). Lean and fat tissue indices were derived from lean and fat mass indexed to height-squared, respectively. The patient's baseline BIS results were used to explore its mortality risk prediction for the entire cohort. Among patients with subsequent BIS measurements, changes of lean and fat mass over time were also examined with survival outcomes. RESULTS: Among all participants (n = 555, PD vintage 38 months), higher baseline lean tissue index was associated with lower mortality after adjusting for fat tissue index and confounders (HR 0.90; 95% CI 0.84-0.97, p = 0.01). However, this association was no longer significance after the final adjustment with serum albumin level (p = 0.06). A total of 136 patients had repeated BIS data. After the interval of 10.1 months during two consecutive BIS measurements, there was a strong inverse correlation between the percentage changes of lean and fat tissue indices (r = - 0.73, p < 0.001). The longitudinal changes in lean mass, either high or low categories, were not significantly associated with all-cause mortality. In contrast, patients who were classified as having low values of fat tissue index (below median) from baseline to the next BIS measurements had a lower odds of death in the univariable (HR 0.32; 95% CI 0.12-0.84, p = 0.02) but not in the adjusted models. CONCLUSION: Among prevalent PD patients, higher baseline lean mass was independently associated with better survival. However, the longitudinal changes in lean mass were not significantly associated with mortality. In contrast, the maintenance of low fat status over time appeared to be associated with a lower likelihood of death among PD population.

Barriers to and constraints of acute peritoneal dialysis in acute kidney injury: A nationwide survey.

This national survey of barriers to and constraints of acute peritoneal dialysis (aPD) in acute kidney injury (AKI) was performed by distributing an online questionnaire to all medical directors of public dialysis units registered with the Nephrology Society of Thailand during September-November 2019. One hundred and thirteen adult facilities responded to the survey covering 75 from 76 provinces (99%) of Thailand. aPD was performed in 66 centres (58%). In facilities where aPD practice was available, the utilization rate was relatively low (<10 cases/year) and limited to specific conditions, including HIV seropositive patients, previous receiving dialysis education and plan and difficult vascular access creation. Only 9% of facilities performed aPD routinely, but interestingly all such units permitted bedside catheter insertion by the nephrologists or internists. The major constraints placed on aPD practice were PD catheter insertion competency, timely catheter insertion support and the medical supporting team's knowledge/competency deficits. aPD for AKI is underutilized in Thailand and limited by the inability to undertake timely PD catheter insertion and knowledge and competency deficits.

Short-Term Immunogenicity Profiles and Predictors for Suboptimal Immune Responses in Patients with End-Stage Kidney Disease Immunized with Inactivated SARS-CoV-2 Vaccine.

INTRODUCTION: Patients with end-stage kidney disease (ESKD) are at risk of severe coronavirus disease and mortality. Immunogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated whole-virus vaccine in patients with ESKD has never been explored. METHODS: We conducted a prospective cohort study of 60 patients with ESKD and 30 healthy controls. All participants received two doses of an inactivated whole-virus SARS-CoV-2 vaccine (Sinovac Biotech Ltd) 4 weeks apart. SARS-CoV-2-specific humoral and cell-mediated immune responses were investigated and referenced with healthy controls. RESULTS: After two doses, an anti-receptor-binding domain immunoglobulin G of 50 AU/ml or greater was present in 53 of 60 patients (88%) in the ESKD group and all participants (100%) in the control group (P = 0.05). The percentage of patients with ESKD and controls with neutralizing antibodies of 35% threshold or greater was 58% and 88%, respectively (P = 0.01). Furthermore, the proportion of patients with ESKD and S1-specific T cell response was comparable with controls (82% vs. 77%, P = 0.45). Old age, high ferritin level, and low absolute lymphocyte count were independently associated with poor humoral immune responses. CONCLUSIONS: Patients with ESKD could develop similar SARS-CoV-2-specific cell-mediated immune responses compared to healthy controls, although suboptimal humoral immune responses were observed following two doses of SARS-CoV-2 vaccination. Therefore, patients with ESKD and the abovementioned factors are at risk of generating inadequate humoral immune responses, and a vaccine strategy to elicit greater immunogenicity among these relatively immunocompromised patients is warranted. (Thai Clinical Trials Registry, TCTR20210226002).

Efficacy and safety of recombinant human erythropoietin (Hema-Plus®) for management of anemia in Thai patients on peritoneal dialysis.

BACKGROUND: Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach. AIM: To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD). METHODS: This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36. RESULTS: All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators' assessment. At week 12, the QoL scores in all domains were significantly increased from baseline. CONCLUSION: Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile.

Protein-Energy Wasting and Mortality Risk Prediction Among Peritoneal Dialysis Patients.

OBJECTIVES: Protein-energy wasting (PEW) is defined as the loss of body protein and energy reserves associated with kidney disease. However, the extent to which PEW contributes to increased mortality among peritoneal dialysis (PD) patients remains unclear. METHODS: This is a retrospective cohort study from 2012 to 2020. The PEW was diagnosed by applying at least 3 of the 4 following criteria: (1) altered serum biochemistry indicated by a serum albumin level of <3.5 g/L; (2) decreased body mass status identified by a body mass index (BMI) of <23 kg/m2 or <10% total body fat; (3) muscle wasting defined by the lean tissue index, calculated as a lean tissue mass normalized to the height-squared in the <10th percentile of the reference population; and (4) low dietary protein intake determined by the normalized protein equivalent of a total nitrogen appearance of <0.8 g/kg/day. The Malnutrition Inflammation Score (MIS) was also examined as an alternative tool for assessment of PEW. RESULTS: The average age of the 555 participants was 57.5 ± 12.6 years. The prevalence of PEW was 27.3%, with 196 deaths observed during the mean follow-up of 25.5 months. Patients with PEW who fulfilled at least 3 of the 4 listed criteria had a higher risk of death in the unadjusted model (hazard ratio 1.61, 95% confidence interval 1.19-2.18, P = .002). However, these associations were attenuated after adjusting for potential confounders. Regarding the individual PEW criterion, decreased serum albumin and low muscle mass were significantly associated with mortality in the multivariable models. In contrast, decreased body mass and low protein intake were not associated with a higher risk of death. High MIS (≥5 points) and each one-point increase in the MIS were also significantly associated with higher risk of death in both unadjusted and adjusted models. CONCLUSIONS: Among PD patients, the presence of PEW was not a better predictor of all-cause mortality than either the altered serum biochemistry (albumin) or low muscle mass criteria. The MIS performed well as an independent predictor of death and might be an option for assessment of PEW status in the PD population.

Hypokalemia in peritoneal dialysis patients in Thailand: the pivotal role of low potassium intake.

OBJECTIVE: Hypokalemia is highly prevalent in chronic peritoneal dialysis (PD) patients worldwide, particularly in Thailand. This study aims to investigate the major determinants of hypokalemia in Thai PD patients. METHODS: A cross-sectional study was performed in chronic PD patients at 4 PD centers in Bangkok, Thailand. Hypokalemia was defined if the average serum potassium level during the last 3 consecutive visits was < 3.5 mEq/L. Patients and/or their caregivers were asked to perform a 3-day dietary food record and take pre- and post-meal pictures following the instructed protocol. Daily dietary nutrients, including potassium, were estimated by a single dietician using INMUCAL-N software. Total potassium excretion was determined by 24-h PD effluents and urine collection. Intracellular and extracellular water values (ICW and ECW, respectively) were measured by electrical bioimpedance assay (BIA) to indirectly explore the role of intracellular potassium shift in hypokalemia. RESULTS: Among 60 eligible PD patients, 19 (31%) had hypokalemia. Hypokalemic patients had significantly lower dietary potassium intake (24.4 ± 11.1 vs. 30.5 ± 9.4 mEq/day, p = 0.031) and lower total potassium excretion (28.5 ± 8.4 vs. 36.7 ± 11.2 mEq/day, p = 0.006) compared to normokalemic patients. Both groups had comparable values of ICW and ECW. On logistic regression, there was no significant correlation between hypokalemia and daily PD exchange volume, total Kt/Vurea, residual renal function, concurrent medications (insulin, diuretics, renin-angiotensin-aldosterone inhibitor, and beta-blockers) or ICW. Low dietary potassium was an independent risk factor for hypokalemia. CONCLUSION: Low dietary potassium intake, rather than increased potassium excretion or intracellular shift, is the major contributing factor of hypokalemia in Thai chronic PD patients. Dietary intervention or potassium supplement protocol should be implemented.

National feasibility survey of peritoneal dialysis key performance indicators in Thailand from provider perspective.

BACKGROUND: Peritoneal dialysis (PD) has been the main method of renal replacement therapy under the "PD First" policy in Thailand since 2008. Initially, the proposed 13 key performance indicators (KPIs) raised feasibility concerns because of inequitable distribution of resources such as laboratory facilities and/or specialized health-care staff for PD care throughout the country. METHODS: Data availability and goals from the health-care providers' perspective were explored using an online questionnaire survey for all PD centers registered with the Nephrology Society of Thailand from May to June 2016. The availability of essential data required for each KPI indicator to achieve the desired target was assessed using a 5-point Likert scale. RESULTS: Of the 197 centers, 119 responded to the survey (response rate of 60.41%). PD indicators with a high percentage of strongly disagree or disagree were "PD adequacy measured in the last 12 months" (26.83%), "Total weekly Kt/V ≥ 1.7" (24.59%), "3-year PD technique survival" (21.31%), "Serum parathyroid levels within 150 to 500 pg/mL" (16.94%), and a "3-year PD patient survival" (19.01%). As many as 34.17%, 39.19%, 27.27%, 28.93%, and 22.00%, respectively, did not anticipate that the targets could be achieved. Based on the findings from this survey, the national committee concluded that these indicators be removed, and only eight PD indicators were launched. CONCLUSION: Given the importance of KPIs for quality assurance and financial reimbursement, inputs from health-care providers especially data availability and achievement of targets should be considered to ensure feasibility before the final list of indicators are launched.

Intraperitoneal Cefepime Monotherapy Versus Combination Therapy of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-Associated Peritonitis: A Multicenter, Open-Label, Noninferiority, Randomized, Controlled Trial.

RATIONALE & OBJECTIVE: Compared to combination therapy, intraperitoneal (IP) cefepime monotherapy for continuous ambulatory peritoneal dialysis (CAPD)-associated peritonitis may provide potential benefits in lowering staff burden, shortening time-consuming antibiotic preparation, and reducing bag contamination risk. This study sought to evaluate whether cefepime monotherapy is noninferior to combination regimens. STUDY DESIGN: Multicenter, open-label, noninferiority, randomized, controlled trial. SETTING & PARTICIPANTS: Adult incident peritoneal dialysis (PD) patients with CAPD-associated peritonitis in 8 PD centers in Thailand. INTERVENTIONS: Random assignment to either IP monotherapy of cefepime, 1g/d, or IP combination of cefazolin and ceftazidime, 1g/d, both given as continuous dosing. OUTCOMES: Primary end point: resolution of peritonitis at day 10 (primary treatment response). SECONDARY OUTCOMES: initial response (day 5), complete cure (relapse/recurrence-free response 28 days after treatment completion), relapsing/recurrent peritonitis, and death from any cause. Noninferiority would be confirmed for the primary outcome if the lower margin of the 1-sided 95% CI was not less than-10% for difference in the primary response rate. A 2-sided 90% CI was used to demonstrate the upper or lower border of the 1-sided 95% CI. RESULTS: There were 144 eligible patients with CAPD-associated peritonitis, of whom 70 and 74 patients were in the monotherapy and combination-therapy groups, respectively. Baseline demographic and clinical characteristics were not different between the groups. The primary response was 82.6% in the monotherapy group and 81.1% in the combination-therapy group (treatment difference, 1.5%; 90% CI, -9.1% to 12.1%; P=0.04). There was no significant difference in the monotherapy group compared with the combination-therapy group in terms of initial response rate (65.7% vs 60.8%; treatment difference, 4.9%; 95% CI, -10.8% to 20.6%; P=0.5) and complete cure rate (80.0% vs 80.6%; treatment difference, -0.6%; 95% CI, -13.9% to 12.8%; P=0.7). Relapsing and recurrent peritonitis occurred in 4.6% and 4.6% of the monotherapy group and 4.2% and 5.6% of the combination-therapy group (P=0.9and P=0.8, respectively). There was nominally higher all-cause mortality in the monotherapy group (7.1% vs 2.7%; treatment difference, 4.4%; 95% CI, -2.6% to 11.5%), but this difference was not statistically significant (P = 0.2). LIMITATION: Not double blind. CONCLUSIONS: IP cefepime monotherapy was noninferior to conventional combination therapy for resolution of CAPD-associated peritonitis at day 10 and may be a reasonable alternative first-line treatment. FUNDING: This study is supported by The Kidney Foundation of Thailand (R5879), Thailand; Rachadaphiseksompotch Fund (RA56/006) and Rachadaphicseksompotch Endorsement Fund (CU-GRS_61_06_30_01), Chulalongkorn University, Thailand; National Research Council of Thailand (156/2560), Thailand; and Thailand Research Foundation (IRG5780017), Thailand. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02872038.

Survival Analysis and Associated Factors in Thai Patients on Peritoneal Dialysis Under the PD-First Policy.

BACKGROUND: The peritoneal dialysis First (PD-First) policy means that PD is the first modality of dialysis chosen for patients with end-stage renal disease (ESRD), as put forth by the Universal Health Coverage (UHC) scheme. It was initiated in Thailand in 2008. Our aim is to analyze patient survival, technique survival, and associated factors. METHODS: Data of PD patients from January 2008 to November 2016 were studied. We calculated patient and technique survival rates (censored for death and kidney transplantation). Factors associated with survival were analyzed by the Cox proportional hazard model. Patient and technique survival rates between 2008 - 2012 and 2013 - 2016 were compared. RESULTS: Our study included 11,477 patients. The mean (standard deviation [SD]) age at initiation of PD was 54.0 (14.4) years. The level of education in 85.2% of cases was illiterate or primary school. A total of 60.9% of patients developed ESRD secondary to diabetes. The 1- to 5-year patient survival rates were 82.6, 71.8, 64.0, 58.5, and 54.0%, respectively. The first-year technique survival rate was 94.8%. The patient and technique survival rates during 2013 - 2016 were better than those seen during 2008 - 2012. Factors associated with lower patient survival rates were: female gender, increased age at start of PD, coverage with civil servant medical benefit scheme, low educational levels, and a history of diabetes. CONCLUSION: Most patients had diabetes and low educational levels as seen in the outcomes in the previous literature. These factors impacted the survival of patients under the PD-First policy.

Multiple extracellular vesicle types in peritoneal dialysis effluent are prominent and contain known biomarkers.

Peritoneal dialysis inevitability results in activation of inflammatory processes and its efficiency is highly variable between patients. An improved method to isolate biomarkers and study pathophysiological mechanisms in peritoneal dialysis effluent (PDE) is expected to be of much benefit for the development of this treatment approach and help with patient management. Extracellular vesicles (EVs) are released as part of normal cellular processes. Their proteome is expected to reflect both type and health of their cell of origin. Although there is a significant interest in using EVs for "liquid biopsies", little is reported of their presence or composition in plentiful dialysis waste fluids, including peritoneal dialysis effluent (PDE). Here we determined the presence of EVs in PDE and subsequently characterized their proteome. EVs were first isolated from PDE using differential centrifugation, then a further enrichment using size exclusion chromatography (SEC) was performed. The presence of EVs was demonstrated using transmission electron microscopy, and their particle counts were investigated using nanoparticle tracking analysis and dynamic light scattering. Using tandem mass spectrometry, marker proteins from three types of EVs i.e. apoptotic bodies, ectosomes, and exosomes were identified. The proteomic results demonstrated that the isolation of EVs by differential centrifugation helped enrich for over 2,000 proteins normally masked by abundant proteins in PDE such as albumin and SEC markedly further improved the isolation of low abundant proteins. Gene ontology analysis of all identified proteins showed the marked enrichment of exosome and membrane-associated proteins. Over 3,700 proteins were identified in total, including many proteins with known roles in peritoneal pathophysiology. This study demonstrated the prominence of EVs in PDE and their potential value as a source of biomarkers for peritoneal dialysis patients.

PD First Policy: Thailand's Response to the Challenge of Meeting the Needs of Patients With End-Stage Renal Disease.

Providing dialysis for end-stage kidney disease (ESKD) patients nationwide in a developing country such as Thailand is challenging. Even after roll-out of the Thai Universal Coverage Scheme in 2002, treatment for ESKD was not covered and patients struggled to afford dialysis. There was an urgent need to improve financial risk protection for patients with ESKD. Advocacy by nephrologists, health economists, and civil society seeking equity in access to dialysis, and responsiveness from policy makers, led to the methodical development of the Peritoneal Dialysis (PD) First policy and marked a turning point in ESKD care in Thailand. Despite the obvious economic concerns and the prevailing popularity of hemodialysis the policy has been strategically and successfully implemented since 2008. The Thai PD First policy has saved the lives of nearly 50,000 ESKD patients being dialyzed under the universal coverage scheme. Despite ongoing challenges the program continues to evolve. This article summarizes the key strategies underlying the policy development and implementation, the integration of home-based dialysis into the well-established Thai health care system, the use of the Chronic Care Model concept in PD care, and the impact of choosing PD as the first choice of dialysis therapy, which has slowed the growth of dialysis costs.

Dialysate White Blood Cell Change after Initial Antibiotic Treatment Represented the Patterns of Response in Peritoneal Dialysis-Related Peritonitis.

Background. Patients with peritoneal dialysis-related peritonitis usually have different responses to initial antibiotic treatment. This study aimed to explore the patterns of response by using the changes of dialysate white blood cell count on the first five days of the initial antibiotic treatment. Materials and Methods. A retrospective cohort study was conducted. All peritoneal dialysis-related peritonitis episodes from January 2014 to December 2015 were reviewed. We categorized the patterns of antibiotic response into 3 groups: early response, delayed response, and failure group. The changes of dialysate white blood cell count for each pattern were determined by multilevel regression analysis. Results. There were 644 episodes in 455 patients: 378 (58.7%) of early response, 122 (18.9%) of delayed response, and 144 (22.3%) of failure episodes. The patterns of early, delayed, and failure groups were represented by the average rate reduction per day of dialysate WBC of 68.4%, 34.0%, and 14.2%, respectively (p value < 0.001 for all comparisons). Conclusion. Three patterns, which were categorized by types of responses, have variable rates of WBC declining. Clinicians should focus on the delayed response and failure patterns in order to make a decision whether to continue medical therapies or to aggressively remove the peritoneal catheter.