The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.
Reductions in IDWG during the past decade were partially explained by reductions in dialysate sodium concentration. Focusing quality improvement strategies on reducing occurrences of high IDWG may improve outcomes in HD patients.
Background International variation in anemia assessment and management practices in chronic kidney disease (CKD) is poorly understood. Methods We performed a cross-sectional analysis of anemia laboratory monitoring, prevalence and management in the prospective Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps). A total of 6766 participants with CKD Stages 3a–5ND from nephrology clinics in Brazil, France, Germany and the USA were included. Results Among patients with anemia (hemoglobin <12 g/dL), 36–58% in Brazil, the USA and Germany had repeat hemoglobin measured and 40–61% had iron indices measured within 3 months of the index hemoglobin measurement. Anemia was more common in the USA and Brazil than in France and Germany across CKD stages. Higher ferritin and lower iron saturation (TSAT) levels were observed with lower hemoglobin levels, and higher ferritin with more advanced CKD. The proportion of anemic patients with ferritin <100 ng/mL or TSAT <20% ranged from 42% in Brazil to 53% in France and Germany, and of these patients, over 40% in Brazil, Germany and the USA, compared with 27% in France, were treated with oral or intravenous iron within 3 months after hemoglobin measurement. The proportion of patients with hemoglobin <10 g/dL treated with erythropoiesis-stimulating agents ranged from 28% in the USA to 57% in Germany. Conclusions Hemoglobin and iron stores are measured less frequently than per guidelines. Among all regions, there was a substantial proportion of anemic patients with iron deficiency who were not treated with iron, highlighting an area for practice improvement in CKD care.
The purpose of this review was to identify, summarize, and critically appraise studies on dietary salt and health outcomes that were published from August 2016 to March 2017. The search strategy was adapted from a previous systematic review on dietary salt and health. Studies that meet standards for methodological quality criteria and eligible health outcomes are reported in detailed critical appraisals. Overall, 47 studies were identified and are summarized in this review. Two studies assessed all‐cause or disease‐specific mortality outcomes, eight studies assessed morbidity reduction‐related outcomes, three studies assessed outcomes related to symptoms/quality of life/functional status, 25 studies assessed blood pressure (BP) outcomes and other clinically relevant surrogate outcomes, and nine studies assessed physiologic surrogate outcomes. Eight of these studies met the criteria for outcomes and methodological quality and underwent detailed critical appraisals and commentary. Five of these studies found adverse effects of salt intake on health outcomes (BP; death due to kidney disease and initiation of dialysis; total kidney volume and composite of kidney function; composite of cardiovascular disease (CVD) events including, and risk of mortality); one study reported the benefits of salt restriction in chronic BP and two studies reported neutral results (BP and risk of CKD). Overall, these articles confirm the negative effects of excessive sodium intake on health outcomes.
The purpose of this review is to identify, summarize, and critically appraise studies on dietary salt and health outcomes that were published from April to July 2016. The search strategy was adapted from a previous systematic review on dietary salt and health. We have revised our criteria for methodological quality and health outcomes, which are applied to select studies for detailed critical appraisals and written commentary. Overall, 28 studies were identified and are summarized in this review. Four of the 28 studies met criteria for methodological quality and health outcomes and five studies underwent detailed critical appraisals and commentary. Three of these studies found adverse effects of salt on health outcomes (chronic kidney disease and blood pressure) and two were neutral (fracture risk/bone mineral density and cognitive impairment). | INTRODUCTIONMeta-analyses and systematic reviews examining the relationship between dietary salt and health outcomes 1,2 have been the basis for consensus that excess salt (sodium) consumption is associated with multiple adverse health outcomes, including a positive causal relationship with blood pressure (BP). The high profile of dietary salt research has resulted in a rapidly growing literature on the health effects of dietary salt. To keep scientific, clinical, and policy stakeholders up to date with the growing body of literature, regularly updated reviews and critical appraisals of studies relating to health outcomes are published in the Journal, alternating with reviews of studies relating to salt reduction implementation programs. 6 The objective of this fourth health outcomes review is to summarize published articles on salt and health outcomes and to highlight and critically appraise the highest-quality articles that were published between April and July 2016. This article also reports on anupdated methodology developed and adopted to ensure an objective review of the most clinically relevant studies. | METHODOLOGYA detailed description of the methodological approach used to identify published articles for this review has been previously reported. 6Briefly, articles were identified on a weekly basis through a MEDLINE search strategy, which was adapted from a previous systematic review used to develop the WHO guideline on dietary sodium intake. 1,2 Figure). Among identified articles, studies were selected to undergo a detailed critical appraisal based on the outcomes examined and methodological quality, as described below. A secondary set of articles was considered for inclusion if judged by the authors to be impactful based on novelty of findings or potential for generating public discourse or scientific controversy or for informing public health policy.Articles were selected for detailed critical appraisal considering a hierarchy of health outcomes, which were those classified based on relevance to patients ( outcome and category I to V outcomes as secondary outcomes, the study was considered for inclusion as long as it met methodological quality criteria.Met...
, MS, † and on behalf of CKDopps Investigators* Objective: Conflicting findings and knowledge gaps exist regarding links between anemia, physical activity, health-related quality of life (HRQOL), chronic kidney disease (CKD) progression, and mortality in moderate-to-advanced CKD. Using the CKD Outcomes and Practice Patterns Study, we report associations of hemoglobin (Hgb) with HRQOL and physical activity, and associations of Hgb and physical activity with CKD progression and mortality in stage 3-5 nondialysis (ND)-CKD patients. Design and Methods: Prospectively collected data were analyzed from 2,121 ND-CKD stage 3-5 patients, aged $18 years, at 43 nephrologist-run US and Brazil CKD Outcomes and Practice Patterns Study-participating clinics. Cross-sectional associations were assessed of Hgb levels with HRQOL and physical activity levels (from validated Kidney Disease Quality of Life Instrument and Rapid Assessment of Physical Activity surveys). CKD progression (first of $40% estimated glomerular filtration rate [eGFR] decline, eGFR,10 mL/min/1.73 m 2 , or end-stage kidney disease) and all-cause mortality with Hgb and physical activity levels were also evaluated. Linear, logistic, and Cox regression analyses were adjusted for country, demographics, smoking, eGFR, serum albumin, very high proteinuria, and 13 comorbidities. Results: HRQOL was worse, with severe anemia (Hgb,10 g/dL), but also evident for mild/moderate anemia (Hgb 10-12 g/dL), relative to Hgb.12 g/dL. Odds of being highly physically active were substantially greater at Hgb.10.5 g/dL. Lower Hgb was strongly associated with greater CKD progression and mortality, even after extensive adjustment. Physical inactivity was strongly associated with greater mortality and weakly associated with CKD progression. Possible residual confounding is a limitation. Conclusion: This multicenter international study provides real-world observational evidence for greater HRQOL, physical activity, lower CKD progression, and greater survival in ND-CKD patients with Hgb levels .12 g/dL, exceeding current treatment guideline recommendations. These findings help inform future studies aimed at understanding the impact of new anemia therapies and physical activity regimens on improving particular dimensions of ND-CKD patient well-being and clinical outcomes.
The purpose of this review was to identify, summarize, and critically appraise studies on dietary salt relating to health outcomes that were published from December 2015 to March 2016. The search strategy was adapted from a previous systematic review on dietary salt and health. Overall, 13 studies were included in the review: one study assessed cardiovascular events, nine studies assessed prevalence or incidence of blood pressure or hypertension, one study assessed kidney disease, and two studies assessed other health outcomes (obesity and nonalcoholic fatty liver disease). Four studies were selected for detailed appraisal and commentary. One study met the minimum methodologic criteria and found an increased risk associated with lower sodium intake in patients with heart failure. All other studies identified in this review demonstrated positive associations between dietary salt and adverse health outcomes. | INTRODUCTIONExcess salt (sodium) consumption is associated with many adverse health effects, including hypertension and cardiovascular mortality.1,2 Based on the evidence from systematic reviews assessing dietary sodium reduction, the World Health Organization (WHO) recommends a sodium intake of <2 g/d (equivalent to 5 g/d of salt) in adults, with lower amounts for children based on their energy requirements relative to those of adults. 3,4 All WHO Member States have agreed on a target of reducing dietary sodium intake by 30%by 2025. 5Regularly updated reviews and critical appraisals of identified studies relating to health outcomes are published in the Journal of Clinical Hypertension, alternating with reviews of studies relating to salt reduction implementation programs. The last review of salt and health outcomes covered studies published between August and November 2015. | METHODOLOGYA detailed description of the methodological approach used to identify and evaluate the literature in this review has been previously published. 7 In summary, articles were identified on a weekly basis through a MEDLINE search strategy. 7 Studies examining the effects of salt on health outcomes, including studies of participants with any comorbidity (with the exception of acute illness), that were published from December 1, 2015 to March 31, 2016, were included in this review.All included studies were assessed for risk of bias by two independent reviewers. Randomized controlled trials (RCTs) were assessed using the Cochrane risk of bias tool. 8 Observational, nonrandomized studies were assessed using a modified Cochrane risk of bias tool. 9 For systematic reviews and meta-analyses, the c tool was applied. 10We identified the subset of included studies that met previously established minimum methodologic criteria for clinical and population studies on dietary salt 11 (Box). Detailed appraisals and written commentary were performed for these studies. Other studies were then selected for detailed review based on two independent reviewers identifying them either as potentially high impact, controversial, or important in terms ...
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