Shared Decision-Making for a Dialysis Modality.

The prevalence of kidney failure continues to rise globally. Dialysis is a treatment option for individuals with kidney failure; after the decision to initiate dialysis has been made, it is critical to involve individuals in the decision on which dialysis modality to choose. This review, based on evidence arising from the literature, examines the role of shared decision-making (SDM) in helping those with kidney failure to select a dialysis modality. SDM was found to lead to more people with kidney failure feeling satisfied with their choice of dialysis modality. Individuals with kidney failure must be cognizant that SDM is an active and iterative process, and their participation is essential for success in empowering them to make decisions on dialysis modality. The educational components of SDM must be easy to understand, high quality, unbiased, up to date, and targeted to the linguistic, educational, and cultural needs of the individual. All individuals with kidney failure should be encouraged to participate in SDM and should be involved in the design and implementation of SDM approaches.

Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial.

BACKGROUND: We compared the clinical effectiveness of a new peritoneal dialysis (PD) product with polyvinyl chloride-containing tubing (Stay Safe Link®, SSL) with the plastic-free alternative (Stay Safe®, STS) in patients on continuous ambulatory peritoneal dialysis (CAPD). METHOD: A multicentre, parallel, randomised, controlled, open-label, non-inferiority trial was conducted. Adult patients receiving CAPD were randomised in a 1:1 ratio to SSL or STS. The primary outcome was the rate of peritonitis after 1 year of follow-up. RESULTS: A total of 472 subjects were randomised (SSL, n = 233; STS, n = 239). One subject in each group was excluded from the analysis as they withdrew consent before the first dialysis dose. Four hundred and seventy subjects (SSL, n = 232; STS, n = 238) were included in the modified intention-to-treat analysis. Non-inferiority between two groups was established as no significant difference was found in peritonitis rate (incident rate ratio: 0.91, 95% CI: 0.65-1.28). No significant difference was detected in weekly Kt/V (p = 0.58) and creatinine clearance (p = 0.55). However, the average ultrafiltration volume was significantly lower in SSL, with a mean difference of 93 ml (p < 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77-3.75). CONCLUSION: SSL was non-inferior in peritonitis rate compared to plastic-free STS over 1 year in patients requiring CAPD. There was no difference in the delivered dialysis dose, but there was a higher rate of device defects with SSL.

Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis.

INTRODUCTION: Peritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making. METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume. ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.

Risk of Peritoneal Dialysis-Related Peritonitis in a Multi-Racial Asian Population.

♦ BACKGROUND: Peritonitis is one of the most common complications of peritoneal dialysis (PD). Understanding the risk factors of peritonitis in a multi-racial Asian population may help to improve outcomes on PD. ♦ METHODS: We conducted a prospective observational study to identify risk factors for PD-related peritonitis over a 1-year period in 15 adult PD centers. All peritonitis episodes were independently adjudicated. ♦ RESULTS: A total of 1,603 participants with a mean age of 51.6 years comprising 52.7% females, 62.6% ethnic Malays, 27.0% Chinese, and 8.1% Indians were recruited. The overall peritonitis rate was 1 episode per 44.0 patient-months with 354 episodes recorded in 282 (17.6%) patients over 15,588 patient-months. Significant risk factors of peritonitis were severe obesity (incidence-rate ratio [IRR] 3.32, 95% confidence interval [CI]: 1.30, 8.45), hypoalbuminemia (IRR 1.61, 95% CI: 1.06, 2.46), Staphylococcus aureus nasal carriage (IRR 2.26, 95% CI: 1.46, 3.50), and use of Fresenius system (Fresenius Medical Care North America, Waltham, MA, USA) (IRR 2.49, 95% CI: 1.27, 4.89). The risk of peritonitis was lower in those on automated PD compared with standard PD (IRR 0.43, 95% CI: 0.25, 0.74), and in centers with a patient-staff ratio of 15 to 29.9 (IRR 0.67, 95% CI: 0.49, 0.90) and ≥ 30 (IRR 0.52, 95% CI: 0.34, 0.80). Prevalent patients and exit-site care with topical antibiotics were also protective against peritonitis. Peritonitis rates varied between racial groups. The IRRs of overall peritonitis and gram-positive peritonitis in Chinese versus other racial groups were 0.65 (95% CI: 0.46, 0.90) and 0.47 (95% CI: 0.24, 0.91), respectively. ♦ CONCLUSIONS: Multiple patient, center, and PD-system factors influence the risk of peritonitis. In the Asian population, there are racial differences in the risk of peritonitis.

Exit-Site Dressing and Infection in Peritoneal Dialysis: A Randomized Controlled Pilot Trial.

UNLABELLED: ♦ OBJECTIVE: Peritoneal dialysis (PD)-related infection is a common cause of catheter loss and the main reason for PD drop-out. Exit-site infection (ESI) is a pathway to developing tunnel infection and peritonitis, hence rigorous exit-site care has always been emphasized in PD therapy. The aim of this study was to evaluate the effect of exit-site dressing vs non-dressing on the rate of PD-related infection. ♦ METHODS: A prospective randomized controlled study was conducted in prevalent PD patients at the Hospital Tuanku Jaafar Seremban, Negeri Sembilan, Malaysia, from April 2011 until April 2013. All patients were required to perform daily washing of the exit site with antibacterial soap during a shower. In the dressing group (n = 54), patients were required to clean their exit site using povidone-iodine after drying, followed by topical mupirocin antibiotic application to the exit site. The exit site was then covered with a sterile gauze dressing and the catheter immobilized with tape. In the non-dressing group (n = 54), patients were not required to do any further dressing after drying. They were only required to apply mupirocin cream to the exit site and then left the exit site uncovered. The catheter was immobilized with tape. The primary outcome was ESI. The secondary outcomes were evidence of tunnel infection or peritonitis. ♦ RESULTS: A total of 97 patients completed the study. There were a total of 12 ESI episodes: 4 episodes in 4 patients in the dressing group vs 8 episodes in 4 patients in the non-dressing group. This corresponds to 1 episode per 241.3 patient-months vs 1 episode per 111.1 patient-months in the dressing and non-dressing groups respectively. Median time to first ESI episode was shorter in the non-dressing than in the dressing group, but not significant (p = 0.25). The incidence of gram-positive ESI in both groups was similar. There were no gram-negative ESI in the non-dressing group compared with 2 in the dressing group. The peritonitis rate was 1 per 37.1 patient-month in the dressing group and 1 per 44.4 patient-months in the non-dressing group. Median time to first peritonitis episode was significantly shorter in the dressing group compared to non-dressing (p = 0.03). There was no impact of dressing disruptions in the occurrence of major PD catheter-related infection. ♦ CONCLUSION: Use of a non-dressing technique with only prophylactic topical mupirocin cream application is effective in preventing PD-related infection. The non-dressing technique is more cost-effective and convenient for PD patients, with fewer disposables.

Survival predictors in paraquat intoxification and role of immunosuppression.

Paraquat poisoning resulted in multiorgan failure and is associated with high mortality. We audited 83 historical cases of paraquat poisoning in past 2 years treated with conventional decontamination and supportive treatment, followed by enrolling 85 patients over a 2 year period into additional immunosuppression with intravenous (i.v.) methylprednisolone and i.v. cyclophosphamide. Our results showed that age, poor renal function and leucocytosis are the main predictors of fatal outcome. Immunosuppression regime rendered higher survival (6 out of 17 patients (35.3%)) versus historical control (1 out of 18 patients (5.6%)) (p = 0.041) in the cohort with admission eGFR < 50 ml/min/1.73 m2 and WBC count > 11,000/µL. In contrast, there was no difference in survival with immunosuppression regime (38 out of 64 patients (59.4%)) compared to historical control (30 out of 52 patients (57.7%)) (p = 0.885) in those with eGFR > 50 ml/min/1.73 m2 or WBC < 11,000/µL at presentation. Multivariable logistic regression showed survival probability = exp(logit)/(1 + exp(logit)), in which logit = 13.962 - (0.233 × ln(age (year))) - (1.344 × ln(creatinine (µmol/L))) - (1.602 × ln(rise in creatinine (µmol/day))) - (0.614 × ln(WBC (,000/µL))) + (2.021 × immunosuppression) and immunosuppression = 1 if given and 0 if not. Immunosuppression therapy yielded odds ratio of 0.132 (95% confidential interval: 0.029-0.603, p = 0.009). In conclusion, immunosuppression therapy with intravenous methylprednisolone and cyclophosphamide may counteract immune mediated inflammation after paraquat poisoning and improve survival of patients with admission eGFR < 50 ml/min/1.73 m2 and WBC count > 11,000/µL.

Determinants of peritoneal membrane function over time.

Changes to peritoneal membrane function over time result in the development of ultrafiltration failure in a proportion of PD patients and pose a risk for the rarer condition of encapsulating peritoneal sclerosis. These changes are characterized by an increase in the transport rate for small solutes owing to increased vascularity and/or peritoneal blood flow and in more severe cases a reduction in the osmotic conductance of the membrane that likely reflects progressive fibrosis. Both of these processes are preceded by exposure of the membrane to glucose when using conventional dialysis solutions, although this usually is necessitated and likely exacerbated by loss of residual renal function and recurrent peritonitis. Mediators of membrane injury and thus potential biomarkers include inflammatory cytokines, notably local interleukin-6 production, which also appears to determine solute transport characteristics at the start of peritoneal dialysis, local production of vascular endothelial growth factor, and transforming growth factor ß-associated epithelial to mesenchymal transition of the mesothelium leading to membrane fibrosis. Low glucose degradation product solutions may ameliorate the mesothelial injury associated with high glucose exposure, but evidence that they prevent or delay changes in membrane function over time is lacking. In the meantime, avoidance of excessive glucose exposure, preservation of residual renal function, and prevention of peritonitis remain the most logical treatment strategies for this problem.

The peritoneal osmotic conductance is low well before the diagnosis of encapsulating peritoneal sclerosis is made.

Encapsulating peritoneal sclerosis (EPS) is a serious condition whose frequency is increasing the longer the duration of peritoneal dialysis. To identify prognostic indicators of EPS, we studied here longitudinal changes in peritoneal membrane function of patients who later developed this complication. We identified all patients with an unequivocal diagnosis of EPS who began their peritoneal dialysis in our unit over a 20-year period and matched each of them for dialysis duration and age with four control patients who completed their dialysis. The dialysate/plasma creatinine ratio increased with time in both groups but was significantly higher in the patients with EPS only at the time their dialysis was discontinued. The ultrafiltration capacity was significantly worse for at least 2 years before stopping dialysis, diverging further at the time dialysis ceased, suggesting reduced osmotic conductance in the EPS patients. Both the glucose exposure rate for the 5 years preceding stoppage of dialysis and exposure to the osmotic agent icodextrin were significantly higher. Residual renal function was less in the EPS group, but there was no significant difference in the rates of peritonitis compared to the control group. The 24 h peritoneal protein clearance was not significantly different in EPS patients, possibly due to a greater fibrous matrix. Thus, our study shows that regular peritoneal membrane function tests can identify most patients at high risk of developing EPS before its occurrence.

Long-term changes in solute and water transport.

The rate of transport of small solutes across the peritoneal membrane is one of the most important measurements in PD patients. Significant between-patient variability is associated with an impact on small solute clearance, ultrafiltration and even survival. Cross-sectional and longitudinal studies show that solute transport generally increases with time on treatment although this is again highly variable between individuals and is likely to represent an increased vascularity of the membrane. Initially, there is a coupled decrease in the ultrafiltration capacity of the membrane that can be explained by the earlier loss of the osmotic gradient leading predominantly to reduced free water transport via aquaporins combined with more fluid reabsorption once the osmotic gradient has dissipated. Subsequently, in some patients a further disproportionate fall in ultrafiltration occurs due to uncoupling of fluid transport from solute transport as a result of a reduction in the osmotic conductance of the membrane. Drivers of this damage appear to be peritonitis, glucose exposure and early loss of residual renal function. Cytokines and growth factors appear to be involved in this process and may prove useful biomarkers of membrane injury in the future.

Peritoneal dialysis after a failed transplant.

Failed transplantation is an increasingly common cause for starting dialysis treatment. As with all patients approaching dialysis there is a need for adequate physical and psychological preparation and yet whilst by definition these individuals are known to health professionals this is not always achieved. It is likely that given adequate information, a significant proportion of these patients would prefer PD on lifestyle grounds. There is increasingly strong evidence that patients commencing PD after transplant failure enjoy overall survival and technique survival that is no different to those new to dialysis, even when other risk factors such as age, comorbidity, race, gender and membrane function are taken into account. The risk of peritonitis is also not different. These patients tend to lose residual renal function more rapidly but this does not translate into worse outcomes. The role and benefit in modulating immune suppressive drugs before and after commencing PD is not clear.

Wernicke's Encephalopthy Associated with Hyperemesis Gravidarum - A Case Report.

Two cases of Wernicke's encephalopathy due to hyperemesis gravidarum are described. The first patient presented with bilateral papilloedema, altered sensorium and the second with bilateral retinal haemorrhages, ophthalmoplegia and nystagmus. Both patients were diagnosed with Wernicke's encephalopathy on clinical ground since there were no laboratory facilities to measure red cell transketolase and thiamine pyrophosphate levels. This is a rare but treatable complication of hyperemesis gravidarum (HG) and due to lack of diagnostic tools, there is often diagnostic uncertainty, delay in commencing appropriate treatment, as well as irreversible damage to the upper brain stem and death.