BackgroundConservative kidney management (CKM) is recognised as an alternative to dialysis for a significant number of older adults with multimorbid stage 5 chronic kidney disease (CKD5). However, little is known about the way CKM is delivered or how it is perceived.AimTo determine the practice patterns for the CKM of older patients with CKD5, to inform service development and future research.Objectives(1) To describe the differences between renal units in the extent and nature of CKM, (2) to explore how decisions are made about treatment options for older patients with CKD5, (3) to explore clinicians’ willingness to randomise patients with CKD5 to CKM versus dialysis, (4) to describe the interface between renal units and primary care in managing CKD5 and (5) to identify the resources involved and potential costs of CKM.MethodsMixed-methods study. Interviews with 42 patients aged > 75 years with CKD5 and 60 renal unit staff in a purposive sample of nine UK renal units. Interviews informed the design of a survey to assess CKM practice, sent to all 71 UK units. Nineteen general practitioners (GPs) were interviewed concerning the referral of CKD patients to secondary care. We sought laboratory data on new CKD5 patients aged > 75 years to link with the nine renal units’ records to assess referral patterns.ResultsSixty-seven of 71 renal units completed the survey. Although terminology varied, there was general acceptance of the role of CKM. Only 52% of units were able to quantify the number of CKM patients. A wide range reflected varied interpretation of the designation ‘CKM’ by both staff and patients. It is used to characterise a future treatment option as well as non-dialysis care for end-stage kidney failure (i.e. a disease state equivalent to being on dialysis). The number of patients in the latter group on CKM was relatively small (median 8, interquartile range 4.5–22). Patients’ expectations of CKM and dialysis were strongly influenced by renal staff. In a minority of units, CKM was not discussed. When discussed, often only limited information about illness progression was provided. Staff wanted more research into the relative benefits of CKM versus dialysis. There was almost universal support for an observational methodology and a quarter would definitely be willing to participate in a randomised clinical trial, indicating that clinicians placed value on high-quality evidence to inform decision-making. Linked data indicated that most CKD5 patients were known to renal units. GPs expressed a need for guidance on when to refer older multimorbid patients with CKD5 to nephrology care. There was large variation in the scale and model of CKM delivery. In most, the CKM service was integrated within the service for all non-renal replacement therapy CKD5 patients. A few units provided dedicated CKM clinics and some had dedicated, modest funding for CKM.ConclusionsConservative kidney management is accepted across UK renal units but there is much variation in the way it is described and delivered. For best practice, and for CKM to be developed and systematised across all renal units in the UK, we recommend (1) a standard definition and terminology for CKM, (2) research to measure the relative benefits of CKM and dialysis and (3) development of evidence-based staff training and patient education interventions.FundingThe National Institute for Health Research Health Services and Delivery Research programme.
Improving Global Outcomes) convened a Controversies Conference titled Blood Pressure in Chronic Kidney Disease (CKD). The purpose of the meeting was to consider which recommendations from the 2012 KDIGO Clinical Practice Guideline for the Management of Blood Pressure in CKD should be reevaluated based on new evidence from clinical trials. Participants included a multidisciplinary panel of clinical and scientific experts. Discussions focused on the optimal means for measuring blood pressure (BP) as well as managing BP in CKD patients. Consistent with the 2012 Guideline, the conference did not address BP management in patients on maintenance dialysis.
BackgroundExperimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis.MethodsSecondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter).ResultsWe found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so via a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes.ConclusionsThe high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.
Background: Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown. Methods: PIVOTAL (Proactive IV irOn Therapy in hemodiALysis patients) is a multicenter, open-label, blinded endpoint, randomized controlled (PROBE) trial. Incident HD adults with a serum ferritin < 400 µg/L and transferrin saturation (TSAT) levels < 30% receiving erythropoiesis-stimulating agents (ESA) were eligible. Enrolled patients were randomized to a proactive, high-dose IV iron arm (iron sucrose 400 mg/month unless ferritin > 700 µg/L and/or TSAT ≥40%) or a reactive, low-dose IV iron arm (iron sucrose administered if ferritin <200 µg/L or TSAT < 20%). We hypothesized that proactive, high-dose IV iron would be noninferior to reactive, low-dose IV iron for the primary outcome of first occurrence of nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for heart failure or death from any cause. If noninferiority is confirmed with a noninferiority limit of 1.25 for the hazard ratio of the proactive strategy relative to the reactive strategy, a test for superiority will be carried out. Secondary outcomes include infection-related endpoints, ESA dose requirements, and quality-of-life measures. As an event-driven trial, the study will continue until at least 631 primary outcome events have accrued, but the expected duration of follow-up is 2–4 years. Results: Of the 2,589 patients screened across 50 UK sites, 2,141 (83%) were randomized. At baseline, 65.3% were male, the median age was 65 years, and 79% were white. According to eligibility criteria, all patients were on ESA at screening. Prior stroke and MI were present in 8 and 9% of the cohort, respectively, and 44% of patients had diabetes at baseline. Baseline data for the randomized cohort were generally concordant with recent data from the UK Renal Registry. Conclusions: PIVOTAL will provide important information about the optimum dosing of IV iron in HD patients representative of usual clinical practice. Trial Registration: EudraCT number: 2013-002267-25.
Arterial stiffness potently predicts mortality in dialysis patients. Pulse-wave analysis permits the non-invasive assessment of indices of arterial stiffness and the central pressure waveform by applanation tonometry. The aim of this study was to assess the reproducibility of pulse-wave analysis in patients with chronic renal failure. A total of 188 subjects (23 healthy controls, along with 71 pre-dialysis, 67 dialysis and 27 transplant patients) took part. Duplicate measurements were recorded of brachial blood pressure using the semi-automated Omron 705 device and of the radial artery pressure waveform using applanation tonometry. The central pressure aortic waveform was then obtained by application of a transfer function incorporated into the SphygmoCor software. Central aortic mean blood pressure (MBP), indices of arterial stiffness [augmentation index (AIx) and time to reflection (TR)] and the subendocardial viability ratio (SEVR) were analysed for intra-observer, inter-observer and long-term reproducibility using Bland-Altman plots. The mean (pS.D.) intra-observer difference was 0p4 % for AIx, 0p20 ms for TR, 0p3 mmHg for aortic MBP and 0p18 % for the SEVR. Inter-observer mean differences were 0p3 % for AIx, 1p7 ms for TR, 1p4 mmHg for aortic MBP and 1p9 % for the SEVR. For the long-term study, the mean differences were k1p9 % for AIx, k2p13 mmHg for aortic MBP, k2p12 ms for TR and 1p29 % for the SEVR. Pulse-wave analysis showed excellent reproducibility in all the studies, and is therefore suitable for use in all patients with chronic renal failure. Further prospective and interventional studies are now required to assess whether AIx and TR are important prognostic indices of cardiovascular events, and therefore relevant surrogate indices of arterial stiffness in this susceptible population.
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