A Low-Protein Diet with a Renal-Specific Oral Nutrition Supplement Helps Maintain Nutritional Status in Patients with Advanced Chronic Kidney Disease

A low-protein diet (LPD) is recommended to patients with non-dialysis advanced chronic kidney disease (CKD) for delaying renal function decline. However, this approach potentially prevents an adequate calorie and micronutrient intake. We examined the influence of an LPD including a renal-specific oral nutrition supplement (RONS) on the nutrition status of patients with stage 3b–5 CKD. This multicenter, open-label study prospectively enrolled patients over 18 years of age, with an estimated glomerular filtration rate (eGFR) between 10 and 45 mL/min/1.73 m2, serum albumin ≥3.0 g/dL, and body mass index ≤30 kg/m2. All participants implemented the LPD with one serving of RONS daily for 6 months. Daily energy intake, nutrition status, renal function, and quality of life were assessed before and after the intervention. Of 53 enrolled patients, 35 (66.0%) completed the study. We found that RONS use increased patients’ energy intake and maintained their serum albumin, nutritional status, and quality of life. Body weight and handgrip strength increased significantly at 6 months after enrollment (p = 0.0357); eGFR slightly decreased at 3 and 6 months after enrollment, suggesting that patients’ residual renal function was preserved. Our findings support the conclusion that patients with non-dialysis advanced CKD may benefit from additional RONS besides their regular diet. Patients with advanced CKD receiving RONS might achieve better nutrition and delay renal function decline.

The incidence, mortality and renal outcomes of acute kidney injury in patients with suspected infection at the emergency department

Background Acute kidney injury (AKI) is a major health problem associated with considerable mortality and morbidity. Studies on clinical outcomes and mortality of AKI in the emergency department are scarce. The aim of this study is to assess incidence, mortality and renal outcomes after AKI in patients with suspected infection at the emergency department. Methods We used data from the SPACE-cohort (SePsis in the ACutely ill patients in the Emergency department), which included consecutive patients that presented to the emergency department of the internal medicine with suspected infection. Hazard ratios (HR) were assessed using Cox regression to investigate the association between AKI, 30-days mortality and renal function decline up to 1 year after AKI. Survival in patients with and without AKI was assessed using Kaplan-Meier analyses. Results Of the 3105 patients in the SPACE-cohort, we included 1716 patients who fulfilled the inclusion criteria. Of these patients, 10.8% had an AKI episode. Mortality was 12.4% for the AKI group and 4.2% for the non-AKI patients. The adjusted HR for all-cause mortality at 30-days in AKI patients was 2.8 (95% CI 1.7–4.8). Moreover, the cumulative incidence of renal function decline was 69.8% for AKI patients and 39.3% for non-AKI patients. Patients with an episode of AKI had higher risk of developing renal function decline (adjusted HR 3.3, 95% CI 2.4–4.5) at one year after initial AKI-episode at the emergency department. Conclusion Acute kidney injury is common in patients with suspected infection in the emergency department and is significantly associated with 30-days mortality and renal function decline one year after AKI.

Enhanced prediction of renal function decline by replacing waist circumference with “A Body Shape Index (ABSI)” in diagnosing metabolic syndrome: a retrospective cohort study in Japan

Background Abdominal obesity as a risk factor for diagnosing metabolic syndrome (MetS) is conventionally evaluated using waist circumference (WC), although WC does not necessarily reflect visceral adiposity. Objective To examine whether replacing WC with “A Body Shape Index (ABSI)”, an abdominal obesity index calculated by dividing WC by an allometric regression of weight and height, in MetS diagnosis is useful for predicting renal function decline. Subjects/Methods In total, 5438 Japanese urban residents (median age 48 years) who participated in a public health screening program for 4 consecutive years were enrolled. Systemic arterial stiffness was assessed by cardio-ankle vascular index (CAVI). The predictability of the new-onset renal function decline (eGFR < 60 mL/min/1.73 m2) by replacing high WC with high ABSI (ABSI ≥ 0.080) was examined using three sets of MetS diagnostic criteria: Japanese, IDF and NCEP-ATPIII. Results In Japanese and NCEP-ATPIII criteria, MetS diagnosed using ABSI (ABSI-MetS) was associated with significantly higher age-adjusted CAVI compared to non-MetS, whereas MetS diagnosed using WC (WC-MetS) showed no association. Kaplan–Meier analysis of the rate of new-onset renal function decline over 4 years (total 8.7%) showed remarkable higher rate in subjects with ABSI-MetS than in those without (log-rank test p < 0.001), but almost no difference between subjects with and without WC-MetS (p = 0.014–0.617). In gender-specific Cox-proportional hazards analyses including age, proteinuria, and treatments of metabolic disorders as confounders, ABSI-MetS (Japanese criteria for both sexes, IDF criteria for men) contributed independently to the new-onset renal function decline. Of these, the contribution of IDF ABSI-MetS disappeared after adjustment by high CAVI in the subsequent analysis. Conclusion In this study, replacing WC with ABSI in MetS diagnostic criteria more efficiently predicted subjects at risk of renal function decline and arterial stiffening.

A prediction model for the decline in renal function in people with type 2 diabetes mellitus: study protocol

Background Chronic kidney disease (CKD) is a well-established complication in people with diabetes mellitus. Roughly one quarter of prevalent patients with diabetes exhibit a CKD stage of 3 or higher and the individual course of progression is highly variable. Therefore, there is a clear need to identify patients at high risk for fast progression and the implementation of preventative strategies. Existing prediction models of renal function decline, however, aim to assess the risk by artificially grouped patients prior to model building into risk strata defined by the categorization of the least-squares slope through the longitudinally fluctuating eGFR values, resulting in a loss of predictive precision and accuracy. Methods This study protocol describes the development and validation of a prediction model for the longitudinal progression of renal function decline in Caucasian patients with type 2 diabetes mellitus (DM2). For development and internal-external validation, two prospective multicenter observational studies will be used (PROVALID and GCKD). The estimated glomerular filtration rate (eGFR) obtained at baseline and at all planned follow-up visits will be the longitudinal outcome. Demographics, clinical information and laboratory measurements available at a baseline visit will be used as predictors in addition to random country-specific intercepts to account for the clustered data. A multivariable mixed-effects model including the main effects of the clinical variables and their interactions with time will be fitted. In application, this model can be used to obtain personalized predictions of an eGFR trajectory conditional on baseline eGFR values. The final model will then undergo external validation using a third prospective cohort (DIACORE). The final prediction model will be made publicly available through the implementation of an R shiny web application. Discussion Our proposed state-of-the-art methodology will be developed using multiple multicentre study cohorts of people with DM2 in various CKD stages at baseline, who have received modern therapeutic treatment strategies of diabetic kidney disease in contrast to previous models. Hence, we anticipate that the multivariable prediction model will aid as an additional informative tool to determine the patient-specific progression of renal function and provide a useful guide to early on identify individuals with DM2 at high risk for rapid progression.

Low rate of worsening renal function after 2 years of treatment with edoxaban in patients from the ETNA-AF-Europe study

Background Use of vitamin K antagonists (VKAs) is associated with a crude event rate of 23% per year for worsening renal function (WRF). Although non-vitamin K antagonist oral anticoagulants (NOACs) have been associated with a lower risk of longitudinal decline in renal function compared with VKAs, available evidence on renal function decline in patients using NOACs is still limited. Furthermore, renal function is a dose reduction criterion for NOACs, which poses an important question about how physicians should treat patients whose renal function worsens over time. Purpose To evaluate the degree of renal function decline in AF patients treated with edoxaban after 2 years of follow-up, and to investigate clinical outcomes of patients with vs without WRF in the ETNA-AF-Europe study. Methods ETNA-AF-Europe is a multinational, multicentre, observational, post-authorisation safety study conducted in 825 sites in 10 European countries. Results are based on a data snapshot taken on 26th October 2020 which include data up to 2 years of follow-up. Patients were excluded from the analysis population if data to calculate estimated glomerular filtration rate [eGFR] were not available for at least one of the follow-up time-points of 1-year and 2-year. We categorised patients (n=9084) into two subgroups: 1) those with WRF (i.e. ≥25% decline in eGFR from baseline; n=918), and 2) those without WRF (n=8166). eGFR was estimated using the Cockcroft-Gault formula. Baseline characteristics and annualised event rates including 95% confidence intervals were analysed using descriptive analyses. Results Of the 13,417 patients in ETNA-AF-Europe who were included in the 2-year follow-up analysis, 9084 were included in this subgroup analysis, of whom 56.2% were male. Baseline eGFR were similar between patients with and without WRF when comparing across the different renal function categories (Table 1). The majority of the edoxaban-treated patients did not experience WRF (89.9%) during the 2 years of follow-up. The proportion of patients with WRF (10.1%) were older, more often frail and had higher rates of underlying comorbidities, such as diabetes, hypertension and heart failure (Table 1). Patients with WRF had higher annualised event rates of all-cause and cardiovascular death than those without (3.78% vs 1.90% and 2.06% vs 0.92%, respectively). Major bleeding and stroke rates were low, but numerically higher in patients with renal worsening compared to those without WRF (Figure 1). Intracranial haemorrhage rates remained low (0.17% vs 0.19%; Figure 1) in both subgroups. Conclusions This subgroup analysis provides real-world evidence for a low risk of WRF in AF patients treated with edoxaban over a 2-year period. Patients with WRF had higher mortality than those without, as well as numerically higher major bleeding and stroke rates. Importantly, intracranial haemorrhage rates remained low irrespective of WRF. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH /