18 research outputs found

    Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy:A Randomized, Double-Blind, Placebo-Controlled Trial

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    BACKGROUND: Fluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan. OBJECTIVE: We performed longitudinal assessments of thoracic bioimpedance in patients with type 2 diabetes mellitus and nephropathy to determine whether a decrease in bioimpedance accurately reflected fluid retention during treatment with atrasentan. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled study in 48 patients with type 2 diabetes mellitus and nephropathy who were receiving stable doses of renin angiotensin system inhibitors and diuretics. METHODS: Patients were randomized 1:1:1 to placebo, atrasentan 0.5 mg, or atrasentan 1.25 mg once daily for 8 weeks. Thoracic bioimpedance, vital signs, clinical exams, and serologies were taken at weeks 1, 2, 4, 6, and 8, with the exception of serum hemoglobin, which was not taken at week 1, and serum brain natriuretic peptide, which was only taken at baseline, week 4, and week 8. RESULTS: Alterations in bioimpedance were more often present in those who received atrasentan than in those who received placebo, though overall differences were not statistically significant. Transient declines in thoracic bioimpedance during the first 2 weeks of atrasentan exposure occurred before or during peak increases in body weight and hemodilution (decreased serum hemoglobin). CONCLUSIONS: We conclude that thoracic bioimpedance did not reflect changes in weight gain or edema with atrasentan treatment in this study. However, the sample size was small, and it may be of interest to explore the use of thoracic bioimpedance in a larger population to understand its potential clinical use in monitoring fluid retention in patients with chronic kidney disease who receive ET receptor antagonists

    AN INTRODUCTION TO RESUSCITATING THE AGES

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    Concussion Screening Evaluation: BESS vs Sway

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    Introduction: Rapid evaluation of concussion is important in the pre-hospital setting as an easy test. It is also useful in the ED, as too often little is done for concussed patients. The Balance Error Scoring System (BESS) is the current gold standard for evaluating balance, one of the best predictors of concussion. SWAY, a new gyroscope based iPhone application, is being proposed as a more sensitive and more objective test than BESS. This study will compare Sway to BESS to determine if there is equal efficacy.Method: 74 scholastic and collegiate athletes were administered baseline balance evaluations using Sway. Sway is scored out of 100 points and uses the iPhoneā€™s gyroscope to measure balance while the device is clutched to the testerā€™s chest with both hands and eyes remain closed. In conjunction with their evaluations, we scored each athlete using BESS. Subjects are assessed one point for the following errors using BESS: Removing hands from the mobile device clutched to their chest; opening the eyes; stepping, stumbling, or falling; remaining out of the test position for five seconds; moving the hip into more than 30Ā° of hip flexion or abduction; or lifting the forefoot or heel. No foam pad was used and subjects used their hands to clutch mobile device to chest instead of keeping hands on hips.Results: The average score of 4.1 on BESS correlates to an average score of 77.1 on Sway. There is moderate to strong correlation between Sway and BESS results that is statistically significant (P\u3c.05). The Sway average score has a STDev of 14.2. The BESS average score has a STDev of 2.9. According to ā€œNormative data for the balance error scoring system: Implications for brain injury evaluationā€ (G.L. Iverson, M.L. Kaarto, and M.S. Koehle), the 76-90th percentile of individuals ages 20-39 scored 4-6 on BESS.Conclusion: Sway is equally, if not more, sensitive than BESS. While BESS is judged by humans and creates the possibility of human error to occur while evaluating subjects, Sway is completely automated so to minimize human error and give a completely objective score. Sway can replace BESS for rapid balance screening and still maintain clinical accuracy. 1) References ā€œNormative data for the balance error scoring system: Implications for brain injury evaluationā€ (G.L. Iverson, M.L. Kaarto, and M.S. Koehle
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