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Kiffmeyer T.K.,Institute of Energy and Environmental Technology | Tuerk J.,Institute of Energy and Environmental Technology | Hahn M.,Institute of Medical Statistics | Stuetzer H.,Institute of Medical Statistics | And 3 more authors.
Annals of Occupational Hygiene | Year: 2013

A large-scale study was carried out in order to determine the contamination level of antineoplastic drugs in pharmacies and to investigate the suitability and effects of wipe sample monitoring at regular intervals. A specific study design was developed. The 130 participating pharmacies were divided into a study and a control group, carrying out five and two wipe sampling cycles, respectively. The work practice was analyzed using questionnaires to identify factors that influence the contamination level. From 1269 wipe samples, 774 (61%) were contaminated with at least one of the analyzed cytotoxic drugs: cyclophosphamide, docetaxel, etoposide, 5-fluorouracil, gemcitabine, ifosfamide, methotrexate, and paclitaxel. A significant decrease of the contamination with cyclophosphamide and 5-fluorouracil was observed in the study group. The Monitoring-Effect Study of Wipe Sampling in Pharmacies method has proven to be a reliable and affordable tool for contamination control. Based on the 90th percentile of the contamination values, a substance-independent performance-based guidance value of 0.1ng cm-2 has been derived. © 2012 The Author.

Milde T.,Institute of Medical Statistics | Schwab K.,Institute of Medical Statistics | Walther M.,Institute of Medical Statistics | Eiselt M.,Institute of Medical Statistics | And 3 more authors.
Physiological Measurement | Year: 2011

Time-variant partial directed coherence (tvPDC) is used for the first time in a multivariate analysis of heart rate variability (HRV), respiratory movements (RMs) and (systolic) arterial blood pressure. It is shown that respiration-related HRV components which also occur at other frequencies besides the RM frequency (= respiratory sinus arrhythmia, RSA) can be identified. These additional components are known to be an effect of the 'half-the-mean-heart- rate-dilemma' ('cardiac aliasing' CA). These CA components may contaminate the entire frequency range of HRV and can lead to misinterpretation of the RSA analysis. TvPDC analysis of simulated and clinical data (full-term neonates and sedated patients) reveals these contamination effects and, in addition, the respiration-related CA components can be separated from the RSA component and the Traube-Hering-Mayer wave. It can be concluded that tvPDC can be beneficially applied to avoid misinterpretations in HRV analyses as well as to quantify partial correlative interaction properties between RM and RSA. © 2011 Institute of Physics and Engineering in Medicine.

Thadhani R.,Harvard University | Karumanchi S.A.,Institute of Medical Statistics | Karumanchi S.A.,University of Cologne | Wenger J.,Harvard University | And 6 more authors.
Journal of the American Society of Nephrology | Year: 2016

Preeclampsia is a devastating complication of pregnancy. Soluble Fms-like tyrosine kinase-1 (sFlt-1) is an antiangiogenic protein believed to mediate the signs and symptoms of preeclampsia. We conducted an open pilot study to evaluate the safety and potential efficacy of therapeutic apheresis with a plasmaspecific dextran sulfate column to remove circulating sFlt-1 in 11 pregnant women (20-38 years of age) with very preterm preeclampsia (23-32 weeks of gestation, systolic BP 140 mmHg or diastolic BP 90 mmHg, new onset protein/creatinine ratio .0.30 g/g, and sFlt-1/placental growth factor ratio .85). We evaluated the extent of sFlt-1 removal, proteinuria reduction, pregnancy continuation, and neonatal and fetal safety of apheresis after one (n=6), two (n=4), or three (n=1) apheresis treatments.Mean sFlt-1 levels were reduced by 18% (range 7%-28%) with concomitant reductions of 44% in protein/creatinine ratios. Pregnancy continued for 8 days (range 2-11) and 15 days (range 11-21) in women treated once and multiple times, respectively, compared with 3 days (range 0-14) in untreated contemporaneous preeclampsia controls (n=22). Transient maternal BP reduction during apheresis wasmanaged by withholDing pre-apheresis antihypertensive therapy, saline prehydration, andreducingbloodflowthrough the apheresis column.Compared with infants born prematurely to untreated women with and without preeclampsia (n=22 per group), no adverse effects of apheresis were observed. In conclusion, therapeutic apheresis reduced circulating sFlt-1 and proteinuria in women with very preterm preeclampsia and appeared to prolong pregnancy without major adverse maternal or fetal consequences. A controlled trial is warranted to confirm these findings.

Er F.,University of Cologne | Nia A.M.,University of Cologne | Dopp H.,University of Cologne | Hellmich M.,Institute of Medical Statistics | And 10 more authors.
Circulation | Year: 2012

Background-Contrast medium-induced acute kidney injury is associated with substantial morbidity and mortality. The underlying mechanism has been attributed in part to ischemic kidney injury. The aim of this randomized, double-blind, sham-controlled trial was to assess the impact of remote ischemic preconditioning on contrast medium-induced acute kidney injury. Methods and Results-Patients with impaired renal function (serum creatinine >1.4 mg/dL or estimated glomerular filtration rate <60 mL • min • 1.73 m) undergoing elective coronary angiography were randomized in a 1:1 ratio to standard care with (n=50) or without ischemic preconditioning (n=50; intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff). Overall, both study groups were at high risk of developing contrast medium-induced acute kidney injury according to the Mehran risk score. The primary end point was the incidence of contrast medium-induced kidney injury, defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after contrast medium exposure. Contrast medium-induced acute kidney injury occurred in 26 patients (26%), 20 (40%) in the control group and 6 (12%) in the remote ischemic preconditioning group (odds ratio, 0.21; 95% confidence interval, 0.07-0.57; P=0.002). No major adverse events were related to remote ischemic preconditioning. Conclusions-Remote ischemic preconditioning before contrast medium use prevents contrast medium-induced acute kidney injury in high-risk patients. Our findings merit a larger trial to establish the effect of remote ischemic preconditioning on clinical outcomes. Clinical Trial Registration-URL: http://www.germanctr.de. Unique identifier: U1111-1118-8098. © 2012 American Heart Association, Inc.

Wolff S.,Evangelisches Krankenhaus Kalk | Terheggen G.,Evangelisches Krankenhaus Duesseldorf | Mueller R.,Dr. Falk Pharma GmbH | Greinwald R.,Dr. Falk Pharma GmbH | And 2 more authors.
Inflammatory Bowel Diseases | Year: 2013

Background: The consistency of endoscopic and histologic findings in patients with ulcerative colitis (UC) has not been elucidated. Choice of assessment may affect study outcomes. Methods: Post hoc analyses were performed using data from 2 randomized, controlled multicenter trials: (1) SAG-26, mesalazine granules for induction of remission in UC (n = 380), and (2) SAG-27, mesalazine granules for maintenance of UC remission (n = 647). Assessments included Clinical Activity Index, Endoscopic Index, modified Disease Activity Index, and Histology Index. Results: In SAG-26, 52 of 380 patients (13.7%) with clinically (Clinical Activity Index >4) and endoscopically (Endoscopic Index ≥4) active UC showed no histological signs of active inflammation (Histology Index ≤1) at baseline. Among endoscopically and histologically active patients, 246 of 327 (75.2%) reached clinical remission versus 48 of 52 patients (92.3%) with active endoscopy but no inflammation on histology (difference, 17.1%; P = 0.006). The difference in the proportion of patients achieving clinical remission according to endoscopy and histology in clinically inactive (Clinical Activity Index ≤4) patients was 30.8% in SAG-26 (at the study end) and 28.1% in SAG-27 (at baseline). In SAG-27, clinical relapse occurred in 21.2% of patients with endoscopic and histologic remission at baseline and 27.1% of patients with some histological inflammation at baseline (P = 0.111). Using the modified Disease Activity Index ≤1 (mucosal healing) instead of the Endoscopic Index score, the difference was similar (21.2% versus 28.0%, P = 0.073). Conclusions: Endoscopic and histologic assessments differ in both active and inactive UC. Overdiagnosis of inflammation using endoscopy versus histology can significantly affect outcomes, at least in studies using induction of clinical remission as an endpoint. The assessment criteria for trials in UC should be reconsidered. Copyright © 2013 Crohn's & Colitis Foundation of America, Inc.

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