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.
METHODS: An exhaustive literature search was performed, in order to identify the relevant studies describing the epidemiology, pathogenesis, nutritional intervention and outcome of PEW in ESRD on hemodialysis.
RESULTS AND CONCLUSION: The pathogenesis of PEW is multifactorial. Loss of appetite, reduced intake of nutrients and altered lean body mass anabolism/catabolism play a key role. Nutritional approach to PEW should be based on a careful and periodic assessment of nutritional status and on timely dietary counseling. When protein and energy intakes are reduced, nutritional supplementation by means of specific oral formulations administered during the hemodialysis session may be the first-step intervention, and represents a valid nutritional approach to PEW prevention and treatment since it is easy, effective and safe. Omega-3 fatty acids and fibers, now included in commercially available preparations for renal patients, could lend relevant added value to macronutrient supplementation. When oral supplementation fails, intradialytic parenteral nutrition can be implemented in selected patients.
METHODS: A systematic review was conducted by searching PubMed, EMBASE and Google scholar databases to identify all relevant papers published in English from 2003 to 2012, using the following keywords: end stage, terminal, chronic, renal, kidney, risk factors, Arab, North Africa and Libya.
RESULTS: In 2003, the reported incidence of ESKD and prevalence of dialysis-treated ESKD in Libya were the same at 200 per million population (pmp). In 2007, the prevalence of dialysis-treated ESKD was 350 pmp, but the true incidence of ESKD was not available. The most recent published WHO data in 2012 showed the incidence of dialysis-treated ESKD had risen to 282 pmp and the prevalence of dialysis-treated ESKD had reached 624 pmp. The leading causes of ESKD were diabetic kidney disease (26.5 %), chronic glomerulonephritis (21.1 %), hypertensive nephropathy (14.6 %) and congenital/hereditary disease (12.3 %). The total number of dialysis centers was 40 with 61 nephrologists. Nephrologist/internist to patient ratio was 1:40, and nurse to patient ratio was 1:3.7. Only 135 living-related kidney transplants had been performed between 2004 and 2007. There were no published data on most macroeconomic and renal service factors.
CONCLUSIONS: ESKD is a major public health problem in Libya with diabetic kidney disease and chronic glomerulonephritis being the leading causes. The most frequent co-morbidities were hypertension, obesity and the metabolic syndrome. In addition to provision of RRT, preventive strategies are also urgently needed for a holistic integrated renal care system.
METHODS: This is a cross-sectional study assessing LVH using echocardiogram in PD patients. Left ventricular mass index (LVMI) was calculated to determine LVH. Chronic fluid overload (overhydration) was assessed using the body composition monitor, and blood pressure (BP) was measured using 24-h ambulatory BP monitoring.
RESULTS: Thirty-one patients (21 females:10 males, 48.97 ± 14.50 years and dialysis vintage 40.0 ± 28.9 months) were studied. More than two-thirds (77.4 %) were hypertensive, and a third (35.5 %) were diabetic. Baseline data included mean serum albumin (37.34 ± 4.43 g/l), weekly Kt/V (2.02 ± 0.23), residual renal function of 68 (0-880) ml and ultrafiltration of 1,606.9 ± 548.6 ml. Majority of patients (80.6 %) had LVH on echocardiogram with LVMI of 136.5 ± 37.8 g/m(2) and overhydration of 2.23 ± 1.77 l. Average systolic BP, diastolic BP and mean arterial pressure were 141.2 ± 23.3, 90.8 ± 19.7 and 107.6 ± 19.6 mmHg, respectively. Patients with LVH had a lower serum albumin (p = 0.003), were more overhydrated (p = 0.010) and were on higher number of anti-hypertensive agents (p ≤ 0.001). Predictors of LVMI were overhydration (p = 0.002), the presence of diabetes (p = 0.008) and the number of anti-hypertensive agents used (p = 0.026). However, overhydration (p = 0.007) was the main predictor of LVH on multivariate analysis.
CONCLUSION: Overhydration is strongly associated with LVH in PD patients.
BACKGROUND: Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.
METHODS: Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis. Baseline characteristics, periprocedural outcomes, and intermediate-term follow-up were summarized.
RESULTS: Patients on hemodialysis at the time of Micra implantation attempt were on average 70.5 ± 13.5 years of age and 59.2% were male. The dialysis patients commonly had hypertension (80%), diabetes (61%), coronary artery disease (39%), and congestive heart failure (27%), and 72% had a condition that the implanting physician felt precluded the use of a transvenous pacemaker. Micra was successfully implanted in 197 patients (98.0%). Reasons for unsuccessful implantation included inadequate thresholds (n = 2) and pericardial effusion (n = 2). The median implantation time was 27 min (interquartile range: 20 to 39 min). There were 3 procedure-related deaths: 1 due to metabolic acidosis following a prolonged procedure duration in a patient undergoing concomitant atrioventricular nodal ablation and 2 deaths occurred in patients who needed surgical repair after perforation. Average follow-up was 6.2 months (range 0 to 26.7 months). No patients had a device-related infection or required device removal because of bacteremia.
CONCLUSIONS: Leadless pacemakers represent an effective pacing option in this challenging patient population on chronic hemodialysis. The risk of infection appears low with an acceptable safety profile. (Micra Transcatheter Pacing Study; NCT02004873; Micra Transcatheter Pacing System Continued Access Study Protocol; NCT02488681; Micra Transcatheter Pacing System Post-Approval Registry; NCT02536118).
Objective: To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure.
Design, Setting, and Participants: The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation.
Interventions: Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks.
Main Outcomes and Measures: The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome.
Results: Of 1415 eligible participants, 567 were randomized (359 [63%] male, 298 [53%] white, 264 [47%] with diabetes; mean [SD] age, 54.8 [14.3] y). The same proportion of fistula failures occurred in the fish oil and placebo arms (128 of 270 [47%] vs 125 of 266 [47%]; relative risk [RR] adjusted for aspirin use, 1.03; 95% CI, 0.86-1.23; P = .78). Fish oil did not reduce fistula thrombosis (60 [22%] vs 61 [23%]; RR, 0.98; 95% CI, 0.72-1.34; P = .90), abandonment (51 [19%] vs 58 [22%]; RR, 0.87; 95% CI, 0.62-1.22; P = .43), or cannulation failure (108 [40%] vs 104 [39%]; RR, 1.03; 95% CI, 0.83-1.26; P = .81). The risk of fistula failure was similar between the aspirin and placebo arms (87 of 194 [45%] vs 83 of 194 [43%]; RR, 1.05; 95% CI, 0.84-1.31; P = .68).
Conclusions and Relevance: Neither fish oil supplementation nor aspirin use reduced failure of new arteriovenous fistulae within 12 months of surgery.
Trial Registration: anzctr.org.au Identifier: CTRN12607000569404.
OBJECTIVE: The objective of this study was to comprehensively evaluate mobile apps used for medication compliance and nutrition tracking for possible use by CKD and ESRD patients.
METHODS: A systematic review framework was applied to the search, screening, and assessment of apps identified and downloaded from the iOS and Android app stores. We selected apps using 13 relevant search terms, narrowed down based on a set of inclusion and exclusion criteria, and then used the Mobile App Rating Scale (MARS), a widely adopted app evaluation tool to assess the effectiveness of apps. The internal consistency and interrater reliability were tested using Cronbach alpha and interclass correlation coefficients (ICCs), respectively.
RESULTS: The MARS total score had excellent internal consistency (Cronbach alpha=.90) and a moderate level of interrater reliability (2-way mixed ICC 0.65). Overall, 11 out of the 12 reviewed apps met the minimum acceptable score of 3.0 in MARS rating. The 3 apps with the highest combined scores were My Kidneys, My Health Handbook (MARS=4.68); My Food Coach (MARS=4.48); and National Kidney Foundation Malaysia (MARS=4.20). The study identified 2 general weaknesses in the existing apps: the apps fell short of accommodating advanced interactive features such as providing motivational feedback and promoting family member and caregiver participations in the app utilization.
CONCLUSIONS: The MARS rating system performed well in the app evaluation. The 3 highest ranked apps scored consistently high across the 5 dimensions specified in MARS. These apps were developed in collaboration with reputable organizations and field experts, demonstrating the importance of expert guidance in developing medical apps.
BACKGROUND: Depression rates are particularly high in those with end-stage renal disease; however, there is limited insight into the range of stressors associated with haemodialysis treatment within the National Health Service contributing to such high rates, particularly those of a cognitive or psychological nature.
DESIGN: A qualitative approach was used to obtain rich, patient-focused data; one-to-one semi-structured interviews were conducted with twenty end-stage renal disease at a UK National Health Service centre.
METHODS: Patients were interviewed during a typical haemodialysis session. Thematic analysis was used to systematically interpret the data. Codes were created in an inductive and cyclical process using a constant comparative approach.
RESULTS: Three themes emerged from the data: (i) fluctuations in cognitive/physical well-being across the haemodialysis cycle, (ii) restrictions arising from the haemodialysis treatment schedule, (iii) emotional impact of haemodialysis on the self and others. The findings are limited to predominantly white, older patients (median = 74 years) within a National Health Service setting.
CONCLUSIONS: Several of the experiences reported by patients as challenging and distressing have so far been overlooked in the literature. A holistic-based approach to treatment, acknowledging all aspects of a patient's well-being, is essential if optimal quality of life is to be achieved by healthcare providers.
RELEVANCE TO CLINICAL PRACTICE: The findings can be used to inform future interventions and guidelines aimed at improving patients' treatment adherence and outcomes, for example, improved reliable access to mental health specialists.
METHODS: Observational study. Nonglaucomatous patients on NIPD underwent systemic and ocular assessment including mean arterial pressure (MAP), body weight, serum osmolarity, visual acuity, IOP measurement, and ASOCT within 2 hours both before and after NIPD. The Zhongshan Angle Assessment Program (ZAAP) was used to measure ASOCT parameters including anterior chamber depth, anterior chamber width, anterior chamber area, anterior chamber volume, lens vault, angle opening distance, trabecular-iris space area, and angle recess area. T tests and Pearson correlation tests were performed with P<0.05 considered statistically significant.
RESULTS: A total of 46 eyes from 46 patients were included in the analysis. There were statistically significant reductions in IOP (-1.8±0.6 mm Hg, P=0.003), MAP (-11.9±3.1 mm Hg, P<0.001), body weight (-0.7±2.8 kg, P<0.001), and serum osmolarity (-3.4±2.0 mOsm/L, P=0.002) after NIPD. All the ASOCT parameters did not have any statistically significant changes after NIPD. There were no statistically significant correlations between the changes in IOP, MAP, body weight, and serum osmolarity (all P>0.05).
CONCLUSIONS: NIPD results in reductions in IOP, MAP, body weight, and serum osmolarity in nonglaucomatous patients.
OBJECTIVE: To investigate the prevalence of symptom burden and severity of ESRD patients and correlate the findings with their psychological status.
METHODS: This was a cross-sectional study of dialyzed (N = 87) and nondialyzed (N = 100) patients. The symptom burden and severity were determined using the Dialysis Symptom Index (DSI) and the psychological assessment using Depression Anxiety Stress Scale 21 (DASS-21).
RESULTS: Symptom severity evaluated using the DSI was comparable in both groups with fatigue as the most common symptom (n = 141, 75.4%), followed by sleep-related, sexual dysfunction, and dry skin problems. The symptom burden for worrying, dry skin and mouth, decreased appetite, numbness, and leg swelling were significant in not dialyzed group (p
MATERIALS AND METHODS: A cross sectional descriptive study was conducted on 72 ESRD patients at a Dialysis Centre in Malaysia. The modified KDQOL-SF™ subscales, kidney disease-targeted scale and 36 item health survey scale questionnaires were used.
RESULTS: The overall health rating was 66.73 ± 11.670 indicating good quality of life. There was no significant difference between quality of life for the different domains according to gender (p >0.05). However, there were significant differences between quality of life in the domain of burden of kidney disease. Physical functioning deteriorated significantly with age (p=0.012) while social functioning was lowest in the 50-65 years age group (p=0.037). Those who had no morbidities had significantly better scores on the effects of kidney (p=0.036), burden of kidney disease (p=0.011) and physical functioning (p=0.025).
CONCLUSIONS: Patients undergoing haemodialysis have been found to have good quality of life despite having ESRD. It is therefore of paramount importance to constantly monitor the standard of care for these patients to enable them to live their life to the fullest.