Segmental bioimpedance in pregnant end stage renal failure patient for dry weight titration and volume management (case report).

BACKGROUND: Volume assessment, dry weight titration, and blood pressure control in pregnant kidney failure patients are often challenging, with physiological fluid accumulation in the trunk and lower limbs and an increased risk of preeclampsia. We used segmental bioimpedance in the volume management of our kidney failure patient on haemodialysis. CASE PRESENTATION: We report a case of a female patient on maintenance haemodiafiltration with no residual kidney function for whom we used segmental bioimpedance to guide dry weight adjustment. At different gestational periods, we targeted a different extracellular to total body water ratio according to body segments. This allowed us to support her high-risk pregnancy, identify her as probably developing preeclampsia and trigger a plan for closer monitoring and delivery during the third trimester when she had rapid weight gain. CONCLUSION: Segmental bioimpedance is a practical, simple, and non-invasive test that can be performed at the dialysis unit and is useful as an adjunct decision-making tool in the management of pregnant dialysis patients.

Chlorhexidine - a commonly used but often neglected culprit of dialysis associated anaphylactic reactions (case report).

BACKGROUND: Hemodialysis-associated anaphylactic reactions are rare and frequently complex in nature due to the sheer number of possible culprit agents. Unfortunately, dialysis is often unavoidable or strictly essential for life-saving solute clearance or fluid removal in patients with end stage kidney failure and those with severe acute kidney injury. It is of utmost importance that the culprit agent is identified and avoided to allow continuation of dialysis treatment as needed. CASE PRESENTATION: We present 2 cases of hemodialysis-associated anaphylactic reactions. These patients developed anaphylactic reactions peri-dialysis and were initially suspected to have dialyser reactions. They were investigated in a controlled healthcare setting and possible culprit agents were systemically identified and eliminated. They both underwent allergy testing and were diagnosed with chlorhexidine allergy. Of note, Case 1 was an incident dialysis patient at the time of presentation and Case 2 was a prevalent dialysis patient. This suggests that the time from initial sensitization to reaction may not always be helpful in determining if a particular agent is the culprit of an anaphylactic reaction. In both cases, the patients were dialysed through a tunnelled dialysis catheter. We postulate that the presence of an exit site, which represents a compromise to the integrity of the skin's epidermal barrier, may have a significant role in the development of these reactions. As chlorhexidine is a widely used disinfectant in hemodialysis, it is imperative that we consider it as a possible culprit agent when these reactions arise. To our knowledge, there are no other reported cases of anaphylaxis secondary to chlorhexidine use in dialysis patients other than a previous report in 2017. Our report also highlights the possibility of these reactions occurring more frequently in patients with damaged epidermal barriers and in patients exposed to higher environmental concentrations of chlorhexidine. These are novel concepts that can be explored with further research. CONCLUSION: Chlorhexidine associated anaphylactic reactions can occur in the peri-dialysis setting and a high index of suspicion is paramount to diagnosis.

Risk assessment of failure during transitioning from in-centre to home haemodialysis.

BACKGROUND: Introducing a de-novo home haemodialysis (HHD) program often raises safety concerns as errors could potentially lead to serious adverse events. Despite the complexity of performing haemodialysis at home without the supervision of healthcare staff, HHD has a good safety record. We aim to pre-emptively identify and reduce the risks to our new HHD program by risk assessment and using failure mode and effects analysis (FMEA) to identify potential defects in the design and planning of HHD. METHODS: We performed a general risk assessment of failure during transitioning from in-centre to HHD with a failure mode and effects analysis focused on the highest areas of failure. We collaborated with key team members from a well-established HHD program and one HHD patient. Risk assessment was conducted separately and then through video conference meetings for joint deliberation. We listed all key processes, sub-processes, step and then identified failure mode by scoring based on risk priority numbers. Solutions were then designed to eliminate and mitigate risk. RESULTS: Transitioning to HHD was found to have the highest risk of failure with 3 main processes and 34 steps. We identified a total of 59 areas with potential failures. The median and mean risk priority number (RPN) scores from failure mode effect analysis were 5 and 38, with the highest RPN related to vascular access at 256. As many failure modes with high RPN scores were related to vascular access, we focussed on FMEA by identifying the risk mitigation strategies and possible solutions in all 9 areas in access-related medical emergencies in a bundled- approach. We discussed, the risk reduction areas of setting up HHD and how to address incidents that occurred and those not preventable. CONCLUSIONS: We developed a safety framework for a de-novo HHD program by performing FMEA in high-risk areas. The involvement of two teams with different clinical experience for HHD allowed us to successfully pre-emptively identify risks and develop solutions.

Filter life and safety of heparin-grafted membrane for continuous renal replacement therapy - A randomized controlled trial.

Polyethyleneimine-layered membrane with grafted heparin (oXiris) may improve filter life during continuous renal replacement therapy (CRRT) in addition to its immunoadsorptive capability, compared with that of conventional membrane. In this single center, prospective, open-label pilot study, we randomized critically ill patients with bleeding risk who underwent anticoagulation-free CRRT, to commence with oXiris or M150 filter with sequential crossover. We examined the filter life with each circuit and its effect on systemic coagulation parameters. We randomized 11 and nine patients to commence CRRT with oXiris and M150 respectively, with 19 oXiris and 20 M150 filter-circuits in all. Patient profiles in both arms were comparable for illness severity and comorbidities. Median filter lives for oXiris versus M150 circuits were 13 h versus 18 h (p = 0.10). Among 11 patients with paired crossover filters, filter lives for 14 oXiris-M150 circuit pairs were 13 h versus 16 h (p = 0.27), and corresponding transmembrane pressures increased to 111 mmHg versus 75 mmHg by 12 h (p = 0.02). Patients' coagulation parameters were comparable following both filter-circuits. CRRT with oXiris (vs. M150) was independently associated with shorter filter life, adjusted for prescribed dose, vascular access, and coagulopathy. Use of oXiris did not prolong filter life over conventional membrane with no evidence of systemic heparin exposure; significant membrane clogging is observed by 12 h with oXiris.

Hyperlactatemia Predicts Citrate Intolerance With Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy.

PURPOSE:: We aim to determine whether hyperlactatemia, which suggests multi-organ dysfunction and impaired organic substrate metabolism, may predict intolerance to regional citrate anticoagulation (RCA) during continuous venovenous hemofiltration (CVVH). METHODS:: We performed a single-center, retrospective observational study in critically ill patients with acute kidney injury or end-stage renal disease and evaluated the association of peak serum lactate levels with citrate intolerance (CI) during the initial 72 hours of RCA-CVVH, defined by serum total-to-ionized calcium >2.5 plus systemic hypocalcemia. RESULTS:: Eighty-eight patients were studied (aged 59 ± 14 years, 66% males, Acute Physiology and Chronic Health Evaluation II: 31 ± 8). Citrate was dosed at median 2.1 mmol/L of blood flow, with citrate load of 30 mmol/h, and CVVH effluent of 43 mL/kg/h. Twenty patients developed CI. Comparing patients with CI versus none, peak lactate levels were 8 (5-11) versus 3 (2-6) mmol/L, calcium replacement was 13 (10-17) versus 11 (8-12) mmol/h, and standard base excess was -4 (-12 to 1) versus 2(-4 to 7) mmol/L, respectively ( P < .05). Citrate intolerance developed in 38%, 44%, and 55%, in patients with peak lactate >4, >6, >7 mmol/L, respectively, versus 7% in those with peak lactate ≤4 mmol/L ( P ≤ .001), despite comparable citrate load and effluent rates across all categories. On multivariate analysis, hyperlactatemia and hyperbilirubinemia predicted CI ( P ≤ .01), which was associated with increasing calcium infusion requirement. Higher peak lactate from >4 to >7 mmol/L predicted CI with graded increase in odds ratio and specificity from 59% to 87%, but the corresponding negative predictive value from 93% to 87%. Area under nonparametric receiver operating characteristic curve for peak lactate and CI was 0.78. CONCLUSION:: Hyperlactatemia predicts CI during RCA-CVVH with reasonable discriminatory performance in critically ill patients. Serum lactate surveillance may help preempt issues with citrate toxicity.

Electronic health records accurately predict renal replacement therapy in acute kidney injury.

BACKGROUND: Electronic health records (EHR) detect the onset of acute kidney injury (AKI) in hospitalized patients, and may identify those at highest risk of mortality and renal replacement therapy (RRT), for earlier targeted intervention. METHODS: Prospective observational study to derive prediction models for hospital mortality and RRT, in inpatients aged ≥18 years with AKI detected by EHR over 1 year in a tertiary institution, fulfilling modified KDIGO criterion based on serial serum creatinine (sCr) measures. RESULTS: We studied 3333 patients with AKI, of 77,873 unique patient admissions, giving an AKI incidence of 4%. KDIGO AKI stages at detection were 1(74%), 2(15%), 3(10%); corresponding peak AKI staging in hospital were 61, 20, 19%. 392 patients (12%) died, and 174 (5%) received RRT. Multivariate logistic regression identified AKI onset in ICU, haematological malignancy, higher delta sCr (sCr rise from AKI detection till peak), higher serum potassium and baseline eGFR, as independent predictors of both mortality and RRT. Additionally, older age, higher serum urea, pneumonia and intraabdominal infections, acute cardiac diseases, solid organ malignancy, cerebrovascular disease, current need for RRT and admission under a medical specialty predicted mortality. The AUROC for RRT prediction was 0.94, averaging 0.93 after 10-fold cross-validation. Corresponding AUROC for mortality prediction was 0.9 and 0.9 after validation. Decision tree analysis for RRT prediction achieved a balanced accuracy of 70.4%, and identified delta-sCr ≥ 148 µmol/L as the key factor that predicted RRT. CONCLUSION: Case fatality was high with significant renal deterioration following hospital-wide AKI. EHR clinical model was highly accurate for both RRT prediction and for mortality; allowing excellent risk-stratification with potential for real-time deployment.

Cost-effectiveness of haemodialysis and peritoneal dialysis for patients with end-stage renal disease in Singapore.

AIM: This study aimed to evaluate the cost-effectiveness of haemodialysis (HD), continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) for patients with end-stage renal disease (ESRD) in Singapore. METHODS: A Markov model was developed to examine the incremental cost-effectiveness ratios (ICERs) of HD, CAPD and APD over the 10-year time horizon from the societal perspective, using clinical data from an observational study and the national renal registry, utilities from published studies and costs from dialysis services providers. The base-case analysis was for a hypothetical cohort of 60-year-old non-diabetic ESRD patients. A high-risk group of 60-year-old diabetic ESRD patients was also studied. RESULTS: In the base-case analysis, the quality-adjusted life-years (QALYs) were 3.27 with CAPD, 3.48 with APD and 4.69 with HD. The total costs were Singapore dollar $169 872 for CAPD, $201 509 for APD and $306 827 for HD. CAPD and HD had extended dominance over APD. The ICER of HD versus CAPD was $96 447 (US$69 121) per QALY. One-way sensitivity analyses indicated that the results were most sensitive to the utility of HD. Probabilistic sensitivity analyses demonstrated that CAPD had the maximum probability of being cost-effective among treatments under evaluation at a willingness-to-pay (WTP) threshold of $60 000 (US$43 000) per QALY. The high-risk group analyses showed similar results. The ICER of HD versus CAPD was $106 281 (US$76 168) per QALY and the probability of CAPD being optimal was the highest using the same WTP threshold. CONCLUSIONS: Our analysis suggested that starting dialysis with CAPD is most cost-effective for ESRD patients in Singapore.

Bimodal Influence of Vitamin D in Host Response to Systemic Candida Infection-Vitamin D Dose Matters.

Vitamin D level is linked to susceptibility to infections, but its relevance in candidemia is unknown. We aimed to investigate the in vivo sequelae of vitamin D3 supplementation in systemic Candida infection. Implicating the role of vitamin D in Candida infections, we showed that candidemic patients had significantly lower 25-OHD concentrations. Candida-infected mice treated with low-dose 1,25(OH)2D3 had reduced fungal burden and better survival relative to untreated mice. Conversely, higher 1,25(OH)2D3 doses led to poor outcomes. Mechanistically, low-dose 1,25(OH)2D3 induced proinflammatory immune responses. This was mediated through suppression of SOCS3 and induction of vitamin D receptor binding with the vitamin D-response elements in the promoter of the gene encoding interferon γ. These beneficial effects were negated with higher vitamin D3 doses. While the antiinflammatory effects of vitamin D3 are well described, we found that, conversely, lower doses conferred proinflammatory benefits in Candida infection. Our study highlights caution against extreme deviations of vitamin D levels during infections.

Effect of cool vs. warm dialysate on toxin removal: rationale and study design.

BACKGROUND: Cool dialysate is often recommended for prevention of intra-dialytic hypotensive episodes in maintenance hemodialysis (HD) patients. However, its effect on toxin removal is not studied. It is known that inter-compartmental resistance is the main barrier for toxin removal. Cool dialysate can potentially increase this resistance by vasoconstriction and thus impair the toxin removal. The aim of this trial is to compare the toxin removal outcome associated with cool vs. warm dialysate. METHOD/DESIGN: This study is based on the hypothesis that dialysate temperature, a potential maneuver to maintain hemodynamic stability during HD, may influence inter-compartmental resistance and hence, toxin removal. Only stable HD patients will be recruited for this study. The quantum of removed toxins will be assessed by the total spent dialysate, which is a gold standard to quantify the efficacy of a single dialysis session. Collected samples will be analyzed for urea, creatinine, phosphate, ß2-microglobulin, and uric acid. The study is a single center, self-controlled, randomized prospective clinical research where 20 study subjects will undergo 2 dialysis sessions: (a) cool dialysis with dialysate at 35.5°C, and (b) warm dialysis with dialysate at 37°C. Pre- and post-dialysis blood samples will be collected to quantify the dialysis adequacy and toxin reduction ratio. DISCUSSION: This is the first clinical research to investigate the effect of dialysate temperature on removal of both small and large-sized toxins. Successful completion of this research will provide important knowledge pertaining to dialysate temperature prescription. Results can also lead to the hypothesis that cool dialysate may help in by preventing intra-dialytic hypotensive episodes, but prolonged prescription of cool dialysate may lead to comorbidities associated with excess toxin accumulation. The new knowledge will encourage for personalized dialysate temperature profiling. TRIAL REGISTRATION: Clinicaltrials.gov Identifier--NCT02064153.

Predicting first-year mortality in incident dialysis patients with end-stage renal disease - the UREA5 study.

We aimed to develop a risk prediction model for first-year mortality (FYM) in incident dialysis patients with end-stage renal disease. We retrospectively examined patient comorbidities and biochemistry, prior to dialysis initiation, using a single-center, prospectively maintained database from 2005-2010, and analyzed these variables in relation to FYM. A total of 983 patients were studied. 22% had left ventricular ejection fraction (LVEF) <45%. FYM was 17%, and independent predictors included URate <500 or >600 µmol/l, LVEF <45% (higher odds ratio if <30%), Age >70 years, Arteriopathies (cerebrovascular and/or peripheral-vascular diseases), serum Albumin <30 g/l, and Alkaline phosphatase >80 U/l (p < 0.05, C-statistic 0.74), and these constitute the acronym UREA5. Using linear modeling, risk weightage/integer of 3 was assigned to LVEF <30%, 2 to age >70 years, and 1 to each remaining variable. Cumulative UREA5 scores of ≤ 1, 2, 3, 4, and ≥ 5 were associated with FYM of 6, 8, 22, 31, and 46%, respectively (p < 0.0001). Increasing UREA5 scores were strongly associated with stepwise worsening of FYM after dialysis initiation.

Randomized Controlled Clinical Trial of the Effect of Treatment with Vitamin K2 on Vascular Calcification in Hemodialysis Patients (Trevasc-HDK).

Introduction: Vitamin K deficiency among patients on hemodialysis (HD) affects the function of matrix GLA protein (MGP), a potent vitamin K-dependent inhibitor of vascular calcification (VC). Methods: We conducted a single-center randomized controlled trial (RCT) on maintenance HD patients to examine if vitamin K2 supplementation can reduce progression of coronary artery calcification (CAC) over an 18-month study period. Patients were randomized to vitamin K2 group receiving menaquinone-7360 µg 3 times/wk or control group. The primary outcome was CAC scores at the end of the study period. The secondary outcomes were aortic valve calcification (AVC), carotid-femoral pulse wave velocity (cfPWV), aortic augmentation index (AIx), dephosphorylated undercarboxylated MGP (dp-ucMGP) levels, major adverse cardiac events (MACE), and vascular access events. Results: Of the 178 patients randomized, follow-up was completed for 138 patients. The CAC scores between the 2 groups were not statistically different at the end of 18 months (relative mean difference [RMD] 0.85, 95% CI 0.55-1.31). The secondary outcomes did not differ significantly in AVC (RMD 0.82, 95% CI 0.34-1.98), cfPWV (absolute mean difference [AMD] 0.55, 95% CI -0.50 to 1.60), and AIx (AMD 0.13, 95% CI -3.55 to 3.80). Supplementation with vitamin K2 did reduce dp-ucMGP levels (AMD -86, 95% CI -854 to -117). The composite outcome of MACE and mortality was not statistically different between the 2 groups (Hazard ratio = 0.98, 95% CI 0.50-1.94). Conclusion: Our study did not demonstrate a beneficial effect of vitamin K2 in reducing progression of VC in this population at the studied dose and duration.

Surface modification of silicone for biomedical applications requiring long-term antibacterial, antifouling, and hemocompatible properties.

Silicone has been used for peritoneal dialysis (PD) catheters for several decades. However, bacteria, platelets, proteins, and other biomolecules tend to adhere to its hydrophobic surface, which may lead to PD outflow failure, serious infection, or even death. In this work, a cross-linked poly(poly(ethylene glycol) dimethacrylate) (P(PEGDMA)) polymer layer was covalently grafted on medical-grade silicone surface to improve its antibacterial and antifouling properties. The P(PEGDMA)-grafted silicone (Silicone-g-P(PEGDMA)) substrate reduced the adhesion of Staphylococcus aureus , Escherichia coli , and Staphylococcus epidermidis , as well as 3T3 fibroblast cells by ≥90%. The antibacterial and antifouling properties were preserved after the modified substrate was aged for 30 days in phosphate buffer saline. Further immobilization of a polysulfobetaine polymer, poly((2-(methacryloyloxy)ethyl)dimethyl-(3-sulfopropyl)ammonium hydroxide) (P(DMAPS)), on the Silicone-g-P(PEGDMA) substrate via thiol-ene click reaction leads to enhanced antifouling efficacy and improved hemocompatibility with the preservation of the antibacterial property. Compared to pristine silicone, the so-obtained Silicone-g-P(PEGDMA)-P(DMAPS) substrate reduced the absorption of bovine serum albumin and bovine plasma fibrinogen by ≥80%. It also reduced the number of adherent platelets by ≥90% and significantly prolonged plasma recalcification time. The results indicate that surface grafting with P(PEGDMA) and P(DMAPS) can be potentially useful for the modification of silicone-based PD catheters for long-term applications.

Telemedicine and Haemodialysis Care during the COVID-19 Pandemic: An Integrative Review of Patient Safety, Healthcare Quality, Ethics and the Legal Considerations in Singapore Practice.

The COVID-19 pandemic has been an unprecedented health crisis for the general population as well as for patients with chronic illnesses such as those requiring maintenance dialysis. Patients suffering from chronic kidney disease requiring dialysis are considered a high-risk population. Multiple reports have highlighted an increased need for intensive care and higher death rates among this group of patients. Most maintenance dialysis patients are in-centre haemodialysis patients who receive treatment in shared facilities (community dialysis centres). The inability to maintain social distancing in these facilities has led to case clustering among patients and staff. This poses a substantial risk to the patients, their household members, and the wider community. To mitigate the risks of COVID-19 transmission, telemedicine was rapidly adopted in the past year by nephrologists and other allied-health staff to provide care via remote consultations and reviews. Telemedicine poses unique challenges even in an era where so much is performed online with a high degree of success and satisfaction. In applying distant clinical care for maintenance haemodialysis patients via telemedicine, there is a need to ensure adequate protection for the health and safety of patients as well as understand the ethical and legal implications of telemedicine. We discussed, in this article, these three core aspects of patient safety and quality, ethics and legal implications in telemedicine, and how each of these is crucial to the safe and effective delivery of care in general as well as unique aspects of this in Singapore.

Fibrillary Glomerulonephritis and Monoclonal Gammopathy: Potential Diagnostic Challenges.

Fibrillary glomerulonephritis (FGN) is a rare glomerular disease featured by the randomly arranged 12- to 24-nm fibrils under electron microscopy (EM). Up to 10% of FGN patients have monoclonal gammopathy. However, distinguishing between FGN as monoclonal gammopathy of renal significance (MGRS) and FGN from other causes with incidental monoclonal gammopathy of undetermined significance (MGUS) can be challenging, as the current way of demonstrating monoclonality is flawed due to (1) the suboptimal sensitivity of kappa staining by immunofluorescence in frozen tissue (IF-F) as compared to pronase-digested paraffin sections (IF-P), causing incorrect labeling of light chain restriction; (2) the unavailability of immunoglobulin G (IgG) subtyping in some centers; and (3) the unavailability of tests demonstrating the monoclonality of highly variable VH or VL domains in immunoglobulin structures in clinical use. The discovery of DnaJ homolog subfamily B member 9 (DNAJB9) allows diagnosis for FGN with less reliance on EM, and the summary of recent studies revealed that genuine MGRS is extremely rare among FGN. Further research integrating IF-P, IgG subtyping, VH or VL domain monoclonality confirmation, and DNAJB9 as diagnostic modalities, with corresponding clinical data including treatment response and prognosis, is required for a better understanding of this subject.

The Implementation and Role of Antigen Rapid Test for COVID-19 in Hemodialysis Units.

As we move into the third year with COVID-19, many countries have attempted to manage the disease as an endemic. However, this is limited by the disease's morbidity and mortality, the emergence of new strains, and the effectiveness of the vaccine. This brief report describes, evaluates, and discusses the implementation of regular antigen rapid tests (ARTs) for COVID-19 in hemodialysis units. We introduced ARTs during the surge in our hemodialysis units. As compliance with the test was mandatory by regulatory requirements, we surveyed patients and caregivers to measure their acceptability, appropriateness, and feasibility of the ART's implementation. Acceptability measured confidence and level of comfort when performing ART tests, while appropriateness measured the perception of the necessity of ARTs, safety in the dialysis unit with the implementation of ARTs, and understanding using a Likert scale. Feasibility measured the perception of the timely start of dialysis treatment and the convenience of the test. Our survey found that ARTs were acceptable to 98% of patients and caregivers, with the majority reporting no discomfort. The majority of the patients agreed that ARTs were appropriate and feasible. We reported successful ART implementation in a healthcare setting with no false-positive or transmission within the unit during this period. Nevertheless, the long-term implementation outcome will require further evaluation.

Telemedicine in the Satellite Dialysis Unit: Is It Feasible and Safe?

Telemedicine has gained popularity during the recent COVID-19 pandemic. Regular and timely physician review is an essential component of care for the maintenance of hemodialysis patients. While it is widely acknowledged that telemedicine cannot fully replace the role of physical review in this group of patients with organ failure, it can perhaps reduce the reliance on physical review or serve as a filter and triage in determining which patient requires actual physical review. The use of technology in any healthcare setting should always align with existing clinical workflow and protocols. We discuss the safety and quality aspects of this new concept applied to the satellite dialysis unit.

Sunitinib-associated hyperammonemic encephalopathy successfully managed with higher intensity conventional hemodialysis: A case report.

RATIONALE: Hyperammonemia encephalopathy is a rare but severe complication that has been reported in association with the use of sunitinib, a tyrosine kinase inhibitor. We report here a unique case of a patient with end stage renal disease that was initiated on sunitinib for metastatic renal cell carcinoma. PATIENT CONCERNS: A 65-year-old man with end stage renal disease on maintenance conventional hemodialysis and had concomitant stable Child-Pugh class B liver cirrhosis consequent of hepatitis C infection was started on sunitinib for metastatic renal cell carcinoma. He developed confusion few weeks after starting therapy with no other indication of worsening liver dysfunction otherwise. DIAGNOSIS: He was later diagnosed with hyperammonemia encephalopathy. INTERVENTIONS: His treatment was discontinued and reinitiated at a lower dose after recovery and titrated according to tolerance. As ammonia is a very low molecular weight molecule and is cleared well with diffusive clearance, we intensified his dialysis regimen by increasing intensity for each session and frequency per week. OUTCOMES: With this change in dialysis regimen, patient was able to continue treatment with sunitinib. LESSONS: Clinicians prescribing sunitinib should be vigilant to monitor for this complication in patients receiving sunitinib, apart from the more usual presentation of hepatotoxicity. We found that a more intensive hemodialysis regimen consisting of 4× a week conventional high-flux hemodialysis (HD) can permit the continuation of treatment with sunitinib in an end stage renal disease (ESRD) patient with Child-Pugh class B liver cirrhosis.

Non-randomized safety and performance evaluation of the av-Guardian vascular access system.

INTRODUCTION: The ability to successfully cannulate the arteriovenous fistula reliably is a critical step in the delivery of hemodialysis therapy. The av-Guardian vascular access system (Advent Access, Singapore) is designed to overcome the technical barrier to establishing reliable blunt needle access in patients with mature arteriovenous fistula. METHODS: This was a first-in-man, prospective, non-randomized trial (registered on the Australian New Zealand Clinical Trial Registry (ACTRN12617000501347)) performed to assess the safety and feasibility of achieving repeatable successful cannulation via av-Guardian vascular access system to facilitate blunt needling in patients with mature arteriovenous fistula. The primary endpoints of the study included rate of successful hemodialysis sessions via av-Guardian vascular access system cannulation over 3 months and safety of the implants. RESULTS: A total of six patients (four patients with brachiocephalic and two with radiocephalic arteriovenous fistula) were enrolled in the study. A pair of av-Guardian vascular access system were implanted, one each at the arterial and venous cannulation sites, under local anesthesia. Overall, the rate of successful cannulation through the av-Guardian vascular access system over 3 months in 216 hemodialysis sessions was 98.1% (212/216) at the arterial site and 94.4% (204/216) at the venous site. Significantly, 90% and 85.5% of the cannulations at the arterial and venous site, respectively, were successful at first attempt. Blood flow rates within the arteriovenous fistula were unaffected by the devices. CONCLUSION: The results demonstrated the safety and feasibility of a subcutaneously implanted, extravascular device in achieving repeatable successful cannulation via a constant site, to facilitate blunt needling in matured arteriovenous fistula in limited number of patients.