Constipation and clinical outcomes in peritoneal dialysis: Results from Thailand PDOPPS.

BACKGROUND: Patient-reported outcome measures (PROMs) are widely recognized as valuable predictors of clinical outcomes in peritoneal dialysis (PD). Our study aimed to explore the connections between patient-reported constipation and clinical outcomes. METHODS: We assessed constipation in patients across 22 facilities participating in the Thailand Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014 to 2017. Constipation diagnosis utilized objective assessment tools such as the Bristol stool form scale (BSFS) and a self-reported questionnaire known as the constipation severity score (CSS). The BSFS is a 7-level scale that visually inspects feces based on texture and morphology, while the CSS measures constipation duration and severity using a 5-point Likert scale for various factors. We employed Cox proportional hazards model regression to determine the associations between constipation and clinical outcomes, including mortality, hemodialysis (HD) transfer and peritonitis. RESULTS: Among 975 randomly selected PD patients from 22 facilities, 845 provided written informed consent, and 729 completed CSS questionnaire. Constipation was prevalent in the PD population (13%), particularly among older patients, those who were caregiver dependent, had diabetes and poorer nutritional status (indicated by lower time-averaged serum albumin, potassium, creatinine and phosphate concentrations). Twenty-seven percent of which experiencing symptoms of constipation for over a year. Notably, self-reported constipation at baseline was significantly associated with a shorter time to first peritonitis and higher rates of peritonitis and death. However, no significant association was found between constipation and HD transfer after adjusting for various factors, including age, gender, PD vintage, comorbidities, shared frailty by study sites and serum albumin. CONCLUSION: Patient-reported constipation independently correlated with increased risks of peritonitis and all-cause mortality, though no such correlation was observed with HD transfer. These findings underscore the need for further investigation to identify effective interventions for constipation in PD patients.

Early as compared to late initiation of twice-weekly hemodialysis and short-term survival among end-stage renal disease patients.

INTRODUCTION: The impact of timing of hemodialysis (HD) for end-stage renal disease (ESRD) patients treated with twice-weekly HD remains unclear. We aimed to determine the effects of late initiation of HD on short-term mortality and hospitalization. METHODS: A multicenter cohort study was conducted in 11 HD centers in Northeastern Thailand (HEmodialysis Network of the NorthEastern Thailand study group). We recruited adult ESRD patients who were treated with twice-weekly HD for more than 3 months and had data on eGFR at HD initiation. Clinical and laboratory values at the time of recruitment were recorded. Late and early (eGFR at start <5 and >5 ml/min/1.73 m2 ) initiations were defined. Outcomes were disease-related death (excluding any accidental deaths) and first hospitalization. Data analysis was performed by multivariable cox-regression analysis. FINDINGS: A total of 407 patients who had data on eGFR at HD initiation (303 in late group and 104 in early group) were included for analysis. There were 56.8% male with a mean age of 55 years. During the 15.1 months of follow-up, there were 27 (6.6%) disease-related deaths. The 1-year survival rate was similar among late and early initiation groups. The incidence density of first hospitalization in the late group was significantly lower than those in the early group (HR adjusted, 0.63; 95% CI, 0.40-0.99, p = 0.047). Among 303 patients who were in the late start group, patients with diabetes had a higher mortality rate (HR, 3.49; 95% CI, 1.40-8.70, p = 0.007) when compared to non-diabetic patients. DISCUSSION: Early initiation of HD at eGFR >5 ml/min/1.73 m2 had no short-term survival benefit compared to the late group in ESRD patients treated with twice-weekly HD for at least 3 months in a resource-limited setting. A survival benefit from an early start of HD was found among diabetic patients.

Spiritual well-being and its relationship with patient characteristics and other patient-reported outcomes in peritoneal dialysis patients: Findings from the PDOPPS.

BACKGROUND: Spiritual well-being (SWB), an individual's understanding of the meaning and purpose of life, may help patients with chronic or terminal illnesses cope with their diseases. This study aimed to assess SWB in patients on peritoneal dialysis (PD), as well as its relationship with patient characteristics and patient-reported outcomes (PRO). METHODS: The data were obtained from questionnaires that formed part of the PD Outcomes and Practice Patterns Study (PDOPPS). Measures used in this study were SWB scores derived from the WHO quality of life, spirituality, religiousness and personal beliefs (WHOQOL-SRPB) tool including 32 items from eight facets; physical (PCS) and mental component summary (MCS) scores of the 12-Item Short-Form Health Survey (SF-12), Center of Epidemiologic Studies Depression Scale-10 (CES-D-10) scores, burden of kidney disease scores and functional status scores. RESULTS: Overall, 529 out of 848 participants (62%) completely responded to the questionnaires and were included in the analysis. Over two-thirds of PD patients (70%) had moderate or higher SWB scores. The SWB scores were significantly lower in patients with age >65 years and unemployed status. SWB scores positively correlated with higher PCS, MCS, burden of kidney disease scores and functional status scores, while negatively correlated with depression scores by CES-D-10 scale. Patients who reported significant depressive symptoms (CES-D-10 score ≥ 10) had significantly lower SWB scores. CONCLUSION: Better SWB was significantly associated with better health-related QOL (HRQOL) and the absence of depressive symptoms. SWB may be an essential consideration in the delivery of high-quality PD.

Implementation of PDOPPS in a middle-income country: Early lessons from Thailand.

BACKGROUND: Despite the implementation of a 'Peritoneal Dialysis (PD) First' policy in Thailand since 2008, nationwide PD practices and patients' outcomes have rarely been reported. METHODS: As part of the multinational PD Outcomes and Practice Patterns Study (PDOPPS), PD patients from 22 PD centres from different geographic regions, sizes and affiliations, representing Thailand PD facilities, have been enrolled starting in May 2016. Demographic, clinical and laboratory data and patients' outcomes were prospectively collected and analysed. RESULTS: The pilot and implementation phases demonstrated excellent concordance between study data and validation data collected at enrolment. In the implementation phase, 848 PD patients (including 262 (31%) incident PD patients) were randomly sampled from 5090 patients in participating centres. Almost all participants (95%) performed continuous ambulatory PD (CAPD), and a high proportion had hypoalbuminemia (67%, serum albumin < 3.5 g/dL), anaemia (42%, haemoglobin <10 g/dL) and hypokalaemia (37%, serum potassium < 3.5 mmol/L). The peritonitis rate was 0.40 episodes/year, but the culture-negative rate was high (0.13 episodes/year, 28% of total episodes). The patients from PD clinics located in Bangkok metropolitan region had higher socio-economic status, more optimal nutritional markers, blood chemistries, haemoglobin level and lower peritonitis rates compared to the provincial regions, emphasizing the centre effect on key success factors in PD. CONCLUSIONS: Participation in the PDOPPS helps unveil the critical barriers to improving outcomes of PD patients in Thailand, including a high prevalence of hypokalaemia, anaemia, poor nutritional status and culture-negative peritonitis. These factors should be acted upon to formulate solutions and implement quality improvement on a national level.

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.

Association of Local Unit Sampling and Microbiology Laboratory Culture Practices With the Ability to Identify Causative Pathogens in Peritoneal Dialysis-Associated Peritonitis in Thailand.

INTRODUCTION: This describes variations in facility peritoneal dialysis (PD) effluent (PDE) culture techniques and local microbiology laboratory practices, competencies, and quality assurance associated with peritonitis, with a specific emphasis on factors associated with culture-negative peritonitis (CNP). METHODS: Peritonitis data were prospectively collected from 22 Thai PD centers between May 2016 and October 2017 as part of the Peritoneal Dialysis Outcomes and Practice Patterns Study. The first cloudy PD bags from PD participants with suspected peritonitis were sent to local and central laboratories for comparison of pathogen identification. The associations between these characteristics and CNP were evaluated. RESULTS: CNP was significantly more frequent in local laboratories (38%) compared with paired PDE samples sent to the central laboratory (12%, P < 0.05). Marked variations were observed in PD center practices, particularly with respect to specimen collection and processing, which often deviated from International Society for Peritoneal Dialysis Guideline recommendations, and laboratory capacities, capabilities, and certification. Lower rates of CNP were associated with PD nurse specimen collection, centrifugation of PDE, immediate transfer of samples to the laboratory, larger hospital size, larger PD unit size, availability of an on-site nephrologist, higher laboratory capacity, and laboratory ability to perform aerobic cultures, undertake standard operating procedures in antimicrobial susceptibilities, and obtain local accreditation. CONCLUSION: There were large variations in PD center and laboratory capacities, capabilities, and practices, which in turn were associated with the likelihood of culturing and correctly identifying organisms responsible for causing PD-associated peritonitis. Deviations in practice from International Society for Peritoneal Dialysis guideline recommendations were associated with higher CNP rates.

A Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial.

BACKGROUND: Treatment of melioidosis comprises intravenous drugs for at least 10 days, followed by oral trimethoprim-sulfamethoxazole (TMP-SMX) for 12 to 20 weeks. Oral TMP-SMX is recommended for 12 weeks in Australia and 20 weeks in Thailand. METHODS: For this open-label, pragmatic, multicenter, noninferiority, randomized controlled trial, we enrolled patients with culture-confirmed melioidosis who had received oral eradication treatment for 12 weeks and had no clinical evidence of active melioidosis. We randomly assigned patients to stop treatment (12-week regimen) or continue treatment for another 8 weeks (20-week regimen). The primary end point was culture-confirmed recurrent melioidosis within 1 year after enrollment. The noninferiority margin was a hazard ratio (HR) of 2.0. The secondary composite end point, combining overall recurrent melioidosis and mortality, was assessed post hoc. RESULTS: We enrolled 658 patients: 322 to the 12-week regimen and 336 to the 20-week regimen. There were 5 patients (2%) in the 12-week regimen and 2 patients (1%) in the 20-week regimen who developed culture-confirmed recurrent melioidosis (HR, 2.66; 95% confidence interval [CI], .52-13.69). The criterion for noninferiority of the primary event was not met (1-sided P = .37). However, all-cause mortality was significantly lower in the 12-week regimen group than in the 20-week regimen group (1 [.3%] vs 11 [3%], respectively; HR, 0.10; 95% CI, .01-.74). The criterion for noninferiority of the secondary composite end point, combining overall recurrent melioidosis and mortality, was met (1-sided P = .022). CONCLUSIONS: Based on the lower total mortality and noninferiority of the secondary composite end point observed, we recommend the 12-week regimen of TMP-SMX for oral eradication treatment of melioidosis. CLINICAL TRIALS REGISTRATION: NCT01420341.

Melioidosis in Thailand: Present and Future.

A recent modelling study estimated that there are 2800 deaths due to melioidosis in Thailand yearly. The Thailand Melioidosis Network (formed in 2012) has been working closely with the Ministry of Public Health (MoPH) to investigate and reduce the burden of this disease. Based on updated data, the incidence of melioidosis is still high in Northeast Thailand. More than 2000 culture-confirmed cases of melioidosis are diagnosed in general hospitals with microbiology laboratories in this region each year. The mortality rate is around 35%. Melioidosis is endemic throughout Thailand, but it is still not uncommon that microbiological facilities misidentify Burkholderia pseudomallei as a contaminant or another organism. Disease awareness is low, and people in rural areas neither wear boots nor boil water before drinking to protect themselves from acquiring B. pseudomallei. Previously, about 10 melioidosis deaths were formally reported to the National Notifiable Disease Surveillance System (Report 506) each year, thus limiting priority setting by the MoPH. In 2015, the formally reported number of melioidosis deaths rose to 112, solely because Sunpasithiprasong Hospital, Ubon Ratchathani province, reported its own data (n = 107). Melioidosis is truly an important cause of death in Thailand, and currently reported cases (Report 506) and cases diagnosed at research centers reflect the tip of the iceberg. Laboratory training and communication between clinicians and laboratory personnel are required to improve diagnosis and treatment of melioidosis countrywide. Implementation of rapid diagnostic tests, such as a lateral flow antigen detection assay, with high accuracy even in melioidosis-endemic countries such as Thailand, is critically needed. Reporting of all culture-confirmed melioidosis cases from every hospital with a microbiology laboratory, together with final outcome data, is mandated under the Communicable Diseases Act B.E.2558. By enforcing this legislation, the MoPH could raise the priority of this disease, and should consider implementing a campaign to raise awareness and melioidosis prevention countrywide.

Peritoneal Dialysis-Related Peritonitis Due to Melioidosis: A Potentially Devastating Condition.

♦ BACKGROUND: Melioidosis, an infectious disease caused by Burkholderia pseudomallei, is endemic in Southeast Asia and Northern Australia. Although a wide range of clinical manifestations from this organism are known, peritonitis associated with peritoneal dialysis (PD) has rarely been reported. ♦ PATIENTS AND METHODS: Peritoneal dialysis patients from all regions in Thailand were eligible for the study if they had peritonitis and either peritoneal fluid or effluent culture positive for B. pseudomallei. Patient data obtained included baseline characteristics, laboratory investigations, treatments, and clinical outcomes. When possible, PD fluid and removed Tenckhoff (TK) catheters were submitted for analyses of minimal inhibitory concentration (MIC) and microbial biofilm, respectively. ♦ RESULTS: Twenty-six patients were identified who were positive for peritoneal B. pseudomallei infection. The recorded mean age was 50 ± 15 (24 - 75) years, and the majority (58%) were female. Most of the cases were farmers living in Northeastern and Northern Thailand. Almost half of the cases had diabetes. Infections were reported commonly during the monsoon season and winter. The clinical presentations of peritonitis were similar to the manifestations from other microorganisms. Nine patients (41%) died (7 from sepsis), 6 fully recovered, and 7 switched to permanent hemodialysis. The mortality was potentially associated with sepsis (p = 0.007), infection during the monsoon season (p = 0.017), high initial dialysate neutrophils (p = 0.045), and high hematocrit (p = 0.045). Although no antibiotic resistance to ceftazidime and carbapenems was detected, approximately 50% of patients died with this treatment. Microbial biofilms were identified on the luminal surface of 4 out of 5 TK catheters, but the removal of the catheter did not alter the outcomes. ♦ CONCLUSION: Peritoneal dialysis-related peritonitis due to melioidosis is uncommon but highly fatal. Increased awareness, early diagnosis, and optimal management are mandatory.

Dialysis dose and risk factors for death among ESRD patients treated with twice-weekly hemodialysis: a prospective cohort study.

BACKGROUND/AIMS: We aimed to define the dosing and risk factors for death in patients undergoing twice-weekly hemodialysis. METHODS: A prospective multi-center cohort study was conducted with one-year observation. Patients treated with twice- or thrice-weekly hemodialysis were identified. Death and first admission were the outcomes. spKt/V was a factor of interest. RESULTS: We enrolled 504 twice-weekly and 169 thrice-weekly hemodialysis patients. The mean weekly values of spKt/V in the two groups were 3.4 and 5.1. The one-year survival rate and times to hospitalization were similar in both groups. The hazard ratios for death in higher spKt/V quartile was not associated with lower mortality, p = 0.70. The four significant predictors for death were serum albumin, HR = 2.6, current smoking, HR = 19.3, age, HR = 1.1, and the Index of Coexistent Disease [ICED], HR = 1.9. CONCLUSION: The effect of spKt/V on short-term mortality was not obvious in twice-weekly dialysis patients. Attention should be paid to patients who smoke, have hypoalbuminemia, are elderly, or have a high ICED.

Prevalence of chronic kidney disease in type 2 diabetes in primary health care unit of Udon Thani province, Thailand.

OBJECTIVE: To determine the prevalence of chronic kidney disease (CKD) in Type 2 diabetes and risk factors of decreased kidney function in Type 2 diabetes at primary health care unit of Udon Thani province. MATERIAL AND METHOD: A descriptive cross-sectional study, cluster random sampling method was conducted from April to August 2007. Seven hundred and sixteen patients were enrolled. Medical histories, physical examinations, and blood tests for glucose, creatinine, total cholesterol, and triglyceride after 9-12 hours fasting were collected. The definition and classification of CKD are classified according to K/DOQI guideline 2002. RESULTS: The mean age of the diabetic patients was 58.70 +/- 9.83 years ranged from 30 to 92 years old. The mean duration of diabetes was 5.53 +/- 4.62 years, the majority (82.41%) had diabetes less than 10 years. More than half (51.82%) were obese (BMI > or = 25 kg/m2). Most of them (89.39%) had universal coverage health assurance. According to the ADA guideline 2006, the target systolic blood pressure, diastolic blood pressure, fasting plasma glucose, total cholesterol, and triglyceride level could be achieved 55.45, 52.93, 36.31, 33.66, and 45.65% respectively. The prevalence of CKD stage 3 to 5 were 27.09 and 25.28% by using C-G and MDRD formulae respectively. The duration of diabetes, diabetes with history of hypertension, triglyceride level, and diabetic retinopathy were significant independent risk factors of the presence of decreased kidney function processed by logistic regression analysis. CONCLUSION: The present study demonstrated the clinical characteristic and the prevalence of decreased kidney function in type 2 diabetes in a primary health care setting. Intensive and optimal treatment of diabetes to slow the progression of long-term complications should be effectively managed by a disciplinary team.