Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial.

BACKGROUND: Granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) are small vessel vasculitides collectively referred to as anti-neutrophil cytoplasm antibody-associated vasculitis (AAV). AAV is associated with high rates of morbidity and mortality due to uncontrolled disease and treatment toxicity. Small randomized trials suggest adjunctive plasma exchange may improve disease control, while observational evidence suggests that current oral glucocorticoid doses are associated with severe infections in patients with AAV. A randomized study of both plasma exchange and glucocorticoids is required to evaluate plasma exchange and oral glucocorticoid dosing in patients with AAV. METHODS/DESIGN: PEXIVAS is a two-by-two factorial randomized trial evaluating adjunctive plasma exchange and two oral glucocorticoid regimens in severe AAV. Five hundred patients are being randomized at centers across Europe, North America, Asia, and Australasia to receive plasma exchange or no plasma exchange, and to receive standard or reduced oral glucocorticoid dosing. All patients receive immunosuppression with either cyclophosphamide or rituximab. The primary outcome is the time to the composite of all-cause mortality and end-stage renal disease.PEXIVAS is funded by the National Institute of Health Research (UK), the Food and Drug Administration (USA), the National Institutes of Health (USA), the Canadian Institute of Health Research (Canada), the National Health and Medical Research Council (Australia), and Assistance Publique (France). Additional in-kind supplies for plasma exchange are provided by industry partners (TerumoBCT, Gambro Australia, and Fresenius Australia). DISCUSSION: This is the largest trial in AAV undertaken to date. PEXIVAS will inform the future standard of care for patients with severe AAV. The cooperation between investigators, funding agencies, and industry provides a model for conducting studies in rare diseases. TRIAL REGISTRATION: Current Controlled Trials: (ISRCTN07757494) and clinicaltrials.gov: (NCT00987389).RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

The effect of extended hours dialysis on sleep quality in a randomised trial

Poor sleep quality is common in haemodialysis patients and associated with worse outcomes. In this pre-specified analysis, we examined the impact of extended hours haemodialysis on sleep quality.The ACTIVE Dialysis trial randomized 200 participants to extended (≥24 hours/week) or standard (target 12-15 hours) hours haemodialysis over 12 months. Sleep quality was measured in the Kidney Disease Quality of Life Short Form 1.3 (KDQOL-SF) by overall sleep quality score (0-10, 10 = "very good") and the sleep subscale (0-100, 100 = 'best possible sleep') every three months via blinded telephone interviewer. The average intervention effect was calculated by mixed linear regression adjusted by time point and baseline score. Factors predicting sleep quality were assessed by multivariate regression analysis.Overall sleep quality score and sleep subscale at baseline were similar in both groups (5.9 [95%CI 5.4-6.4] vs 6.3 [5.9-6.8]; 65.0 [60.9-69.1] vs 63.2 [59.1-67.3]; extended and standard hours respectively). Extended hours haemodialysis led to a non-significant improvement in overall sleep quality score (average intervention effect 0.44 (-0.01-0.89), p=0.053) and sleep subscale (average intervention effect 3.58 (-0.02-7.18), p= 0.051). Poor sleep quality was associated with being female and with current smoking. Sleep quality was positively associated with EuroQol-5D (EQ5D) and the SF-36 Physical Component and Mental Component Summary Scores but not with hospitalisations.Sleep quality was not significantly improved by extended hours dialysis in this study. Sleep quality is positively correlated with quality of life in haemodialysis patients and is poorer in women and current smokers

Sugar Sweetened Beverage Consumption among Adults with Gout or Type 2 Diabetes.

Current guidelines for the management of type 2 diabetes and gout recommend that people with these conditions limit their sugar sweetened beverage (SSB) intake. We examined self-reported SSB intake among New Zealand adults with gout or type 2 diabetes, including those on hemodialysis.1023 adults with gout and 580 adults (including 206 receiving hemodialysis) with type 2 diabetes, participated in this study of between 2009 and 2012. Participants completed an interviewer-administered SSB intake question "how many sugar sweetened drinks (including fruit juice), but not including diet drinks, do you normally drink per day?" SSB consumption was recorded as a circled number 0, 1, 2, 3, 4, 5, or >5, cans or large glasses (300 mL) per day.Consuming one or more SSB per day was reported by 64% (622/1023) of subjects with gout, 49% (176/374) with type 2 diabetes without dialysis, and 47% (96/206) with diabetes on dialysis. Consuming four or more SSBs per day was reported by 18% (179/1023), 9% (31/374) and 9% (18/206), respectively. Such high consumers of SSB were characterized after multivariable analysis to be more likely to be male (adjusted odds ratio (OR) 1.8; 95% confidence interval 1.1-2.9), younger in age (40 vs 65 years: 1.6; 1.1-2.3), current smoker (5.2; 2.7-10.1), obese (BMI 41 vs 26 kg/m(2): 1.4; 1-1.9), and report Māori (1.8; 1.2-2.8) or Pacific (1.6; 1.1-2.5) ancestry, compared to Caucasian. People with gout were more likely to report heavy SSB intake compared to people with diabetes (OR 2.4, 95% CI 1.5-3.9). Heavy SSB consumption reported by people with diabetes was similar if they did or did not require dialysis.A high proportion of patients with gout and type 2 diabetes, including those on haemodialysis, are not responding to health messages to abstain from SSB consumption

Characteristics of subjects by disease category.

<p>* Exercise category was defined as 1 for sedentary, 2 for moderately active, 3 for regular strenuous exercise and 4 for regular hard physical training.</p><p>Characteristics of subjects by disease category.</p

Multivariable associations with heavy SSB consumption patterns.

<p>*Adjusted for all other variables present in table</p><p>^†For continuous variables comparisons were taken at the 16^th and 84^th centiles.</p><p>Multivariable associations with heavy SSB consumption patterns.</p

Characteristics of heavy SSB consumers.

<p>* Exercise category was defined as 1 for sedentary, 2 for moderately active, 3 for regular strenuous exercise and 4 for regular hard physical training.</p><p>Characteristics of heavy SSB consumers.</p