Selective Cytopheretic Inhibitory Device With Regional Citrate Anticoagulation and Portable Sorbent Dialysis

Selective cytopheretic inhibitory device (SCD) therapy is an immunomodulatory treatment provided by a synthetic biomimetic membrane in an extracorporeal circuit, which has shown promise in preclinical large animal models of severe sepsis as well as in clinical trials treating patients with acute kidney injury and multiple organ failure. During SCD therapy, citrate is administered to lower ionized calcium levels in blood for anticoagulation and inhibition of leukocyte activation. Historically, citrate has been known to interfere with sorbent dialysis, therefore, posing a potential issue for the use of SCD therapy with a portable dialysis system. This sorbent dialysis SCD (sorbent SCD) would be well suited for battlefield and natural disaster applications where the water supply for standard dialysis is limited, and the types of injuries in those settings would benefit from SCD therapy. In order to explore the compatibility of sorbent and SCD technologies, a uremic porcine model was tested with the Allient sorbent dialysis system (Renal Solutions Incorporated, Fresenius Medical Care, Warrendale, PA, USA) and concurrent SCD therapy with regional citrate anticoagulation. The hypothesis to be assessed was whether the citrate load required by the SCD could be metabolized prior to recirculation from systemic blood back into the therapeutic circuit. Despite the fact that the sorbent SCD maintained urea clearance without any adverse hematologic events, citrate load for SCD therapy caused an interaction with the sorbent column resulting in elevated, potentially toxic aluminum levels in dialysate and in systemic blood. Alternative strategies to implement sorbent‐SCD therapy will be required, including development of alternate urease‐sorbent column binding chemistry or further changes to the sorbent‐SCD therapeutic circuit along with determining the minimum citrate concentration required for efficacious SCD treatment.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/96390/1/aor1541.pd

On Replacing Peer Review with Legal Challenge in Scientific Research: An Opinion

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/74869/1/j.1525-139X.1994.tb00817.x.pd

Does “Hidden Undercuffing” Occur Among Obese Patients? Effect of Arm Sizes and Other Predictors of the Difference Between Wrist and Upper Arm Blood Pressures

J Clin Hypertens (Greenwich). 2010;12:82–88. © 2009 Wiley Periodicals, Inc. Arm size can affect the accuracy of blood pressure (BP) measurement, and “undercuffing” of large upper arms is likely to be a growing problem. Therefore, the authors investigated the relationship between upper arm and wrist readings. Upper arm and wrist circumferences and BP were measured in 261 consecutive patients. Upper arm auscultation and wrist BP was measured in triplicate, rotating measurements every 30 seconds between sites. Upper arm BP was 131.9±20.6/71.6±12.6 mm Hg in an obese population (body mass index, 30.6±6.6 kg/m 2 ) with mean upper arm size of 30.7±5.1 cm. Wrist BP was higher (2.6±9.2 mm Hg and 4.9±6.6 mm Hg, respectively, P <.001); however, there was moderate concordance for the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) strata (κ value=0.27–0.71), and the difference was ≥5 mm Hg in 72% of the patients. The authors conclude that there was poor concordance between arm and wrist BP measurement and found no evidence that “hidden undercuffing” was associated with obesity; therefore, they do not support routine use of wrist BP measurements.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/78621/1/j.1751-7176.2009.00222.x.pd

Design and objectives of the South American youth/child cardiovascular and environmental (SAYCARE) Study

ABSTRACT: The purpose of this paper is to introduce the overarching study design of the South American Youth/Child Cardiovascular and Environmental (SAYCARE) study, which is an observational multicenter feasibility study held in seven South American cities: Buenos Aires (Argentina), Lima (Peru), Medellin (Colombia), Montevideo (Uruguay), Santiago (Chile), and Sao Paulo and Teresina (Brazil). Children and ~ adolescents (3-17 years of age) were studied. Methods: The data management systems, quality assurance monitoring activities, standardized operating procedure manuals, and training and study management are addressed in this paper. Various quality controls to ensure the collection of valid and reliable data are also discussed. Results and Conclusions: Data were obtained from 237 preschoolers and schoolchildren and 258 adolescents during the validation phase measurements. The results of the SAYCARE study are expected to provide higher accuracy in the assessment of cardiovascular disease risk factors, including eating behaviors, body composition, physical activity, sedentary behaviors, lipid profiles and cardiovascular health biomarkers, oral health, social conditions, environmental factors and home environment, and their determinants in children and adolescents from ages 3 to 17 in seven South American cities

EVOTECH® endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy

<p>Abstract</p> <p>Background</p> <p>The objective of this study was to perform simulated-use testing as well as a clinical study to assess the efficacy of the EVOTECH^®Endoscope Cleaner and Reprocessor (ECR) cleaning for flexible colonoscopes, duodenoscopes, gastroscopes and bronchoscopes. The main aim was to determine if the cleaning achieved using the ECR was at least equivalent to that achieved using optimal manual cleaning.</p> <p>Methods</p> <p>Simulated-use testing consisted of inoculating all scope channels and two surface sites with Artificial Test Soil (ATS) containing 10⁸cfu/mL of <it>Enterococcus faecalis, Pseudomonas aeruginosa </it>and <it>Candida albicans</it>. Duodenoscopes, colonoscopes, and bronchoscopes (all Olympus endoscopes) were included in the simulated use testing. Each endoscope type was tested in triplicate and all channels and two surface sites were sampled for each scope. The clinical study evaluated patient-used duodenoscopes, bronchoscopes, colonoscopes, and gastroscopes (scopes used for emergency procedures were excluded) that had only a bedside flush prior to being processed in the ECR (i.e. no manual cleaning). There were 10 to 15 endoscopes evaluated post-cleaning and to ensure the entire ECR cycle was effective, 5 endoscopes were evaluated post-cleaning and post-high level disinfection. All channels and two external surface locations were sampled to evaluate the residual organic and microbial load. Effective cleaning of endoscope surfaces and channels was deemed to have been achieved if there was < 6.4 μg/cm²of residual protein, < 1.8 μg/cm²of residual hemoglobin and < 4 Log₁₀viable bacteria/cm². Published data indicate that routine manual cleaning can achieve these endpoints so the ECR cleaning efficacy must meet or exceed these to establish that the ECR cleaning cycle could replace manual cleaning</p> <p>Results</p> <p>In the clinical study 75 patient-used scopes were evaluated post cleaning and 98.8% of surfaces and 99.7% of lumens met or surpassed the cleaning endpoints set for protein, hemoglobin and bioburden residuals. In the simulated-use study 100% of the Olympus colonoscopes, duodenoscopes and bronchoscopes evaluated met or surpassed the cleaning endpoints set for protein, and bioburden residuals (hemoglobin was not evaluated).</p> <p>Conclusions</p> <p>The ECR cleaning cycle provides an effective automated approach that ensures surfaces and channels of flexible endoscopes are adequately cleaned after having only a bedside flush but no manual cleaning. It is crucial to note that endoscopes used for emergency procedures or where reprocessing is delayed for more than one hour MUST still be manually cleaned prior to placing them in the ECR.</p