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Sakran J.V.,Inova Regional Trauma Center | Sakran J.V.,Inova Research Center | Sakran J.V.,The Surgical Center | Michetti C.P.,Inova Regional Trauma Center | And 10 more authors.
Journal of Trauma and Acute Care Surgery | Year: 2012

BACKGROUND: Procalcitonin (PCT), the prohormone of calcitonin, has an early and highly specific increase in response to systemic bacterial infection. The objectives of this study were to determine the natural history of PCT for patients with critical illness and trauma, the utility of PCT as a marker of sepsis versus systemic inflammatory response syndrome (SIRS), and the association of PCT level with mortality. METHODS: PCT assays were done on eligible patients with trauma admitted to the trauma intensive care unit (ICU) of a Level I trauma center from June 2009 to June 2010, at hours 0, 6, 12, 24, and daily until discharge from ICU or death. Patients were retrospectively diagnosed with SIRS or sepsis by researchers blinded to PCT results. RESULTS: A total of 856 PCT levels from 102 patients were analyzed, with mean age of 49 years, 63% male, 89% blunt trauma, mean Injury Severity Score of 21, and hospital mortality of 13%. PCT concentration for patients with sepsis, SIRS, and neither were evaluated. Mean PCT levels were higher for patients with sepsis versus SIRS (p < 0.0001). Patients with a PCT concentration of 5 ng/mL or higher had an increased mortality when compared with those with a PCT of less than 5 ng/mL in a univariate analysis (odds ratio, 3.65; 95% confidence interval, 1.03-12.9; p = 004). In a multivariate logistic analysis, PCT was found to be the only significant predictor for sepsis (odds ratio, 2.37; 95% confidence interval,1.23-4.61, p = 001). CONCLUSION: PCT levels are significantly higher in ICU patients with trauma and sepsis and may help differentiate sepsis from SIRS in critical illness. An elevated PCT level was associated with increased mortality. Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.


Bagla S.,Inova Alexandria Hospital | Martin C.P.,Inova Health System | Van Breda A.,Inova Alexandria Hospital | Sheridan M.J.,Inova Research Center | And 4 more authors.
Journal of Vascular and Interventional Radiology | Year: 2014

Purpose To report early findings from a prospective United States clinical trial to evaluate the efficacy and safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH). Materials and Methods From January 2012 to March 2013, 72 patients were screened and 20 patients underwent treatment. Patients were evaluated at baseline and selected intervals (1, 3, and 6 mo) for the following efficacy variables: American Urological Association (AUA) symptom score, quality of life (QOL)-related symptoms, International Index of Erectile Function score, peak urine flow rate, and prostate volume (on magnetic resonance imaging at 6 mo). Complications were monitored and reported per Society of Interventional Radiology guidelines. Results Embolization was technically successful in 18 of 20 patients (90%); bilateral PAE was successful in 18 of 19 (95%). Unsuccessful embolizations were secondary to atherosclerotic occlusion of prostatic arteries. Clinical success was seen in 95% of patients (19 of 20) at 1 month, with average AUA symptom score improvements of 10.8 points at 1 month (P <.0001), 12.1 points at 3 months (P =.0003), and 9.8 points at 6 months (P =.06). QOL improved at 1 month (1.9 points; P =.0002), 3 months (1.9 points; P =.003), and 6 months (2.6 points; P =.007). Sexual function improved by 34% at 1 month (P =.11), 5% at 3 months (P =.72), and 16% at 6 months (P =.19). Prostate volume at 6 months had decreased 18% (n = 5; P =.05). No minor or major complications were reported. Conclusions Early results from this clinical trial indicate that PAE offers a safe and efficacious treatment option for men with BPH. © 2014 SIR.


Niedzwiecki D.,Duke University | Niedzwiecki D.,University of North Carolina at Chapel Hill | Niedzwiecki D.,Dana-Farber Cancer Institute | Niedzwiecki D.,Massachusetts General North Shore Cancer Center | And 353 more authors.
Journal of Clinical Oncology | Year: 2011

Purpose: We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome. Patients and Methods: After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy. Results: Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95% CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95% CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer. Conclusion: Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients. © 2011 by American Society of Clinical Oncology.


PubMed | Georgetown University, Inova Health System, Inova Alexandria Hospital and Inova Research Center
Type: Clinical Trial | Journal: Journal of vascular and interventional radiology : JVIR | Year: 2013

To report early findings from a prospective United States clinical trial to evaluate the efficacy and safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH).From January 2012 to March 2013, 72 patients were screened and 20 patients underwent treatment. Patients were evaluated at baseline and selected intervals (1, 3, and 6 mo) for the following efficacy variables: American Urological Association (AUA) symptom score, quality of life (QOL)-related symptoms, International Index of Erectile Function score, peak urine flow rate, and prostate volume (on magnetic resonance imaging at 6 mo). Complications were monitored and reported per Society of Interventional Radiology guidelines.Embolization was technically successful in 18 of 20 patients (90%); bilateral PAE was successful in 18 of 19 (95%). Unsuccessful embolizations were secondary to atherosclerotic occlusion of prostatic arteries. Clinical success was seen in 95% of patients (19 of 20) at 1 month, with average AUA symptom score improvements of 10.8 points at 1 month (P < .0001), 12.1 points at 3 months (P = .0003), and 9.8 points at 6 months (P = .06). QOL improved at 1 month (1.9 points; P = .0002), 3 months (1.9 points; P = .003), and 6 months (2.6 points; P = .007). Sexual function improved by 34% at 1 month (P = .11), 5% at 3 months (P = .72), and 16% at 6 months (P = .19). Prostate volume at 6 months had decreased 18% (n = 5; P = .05). No minor or major complications were reported.Early results from this clinical trial indicate that PAE offers a safe and efficacious treatment option for men with BPH.


Patel K.,Duke Clinical Research Institute | Patel K.,Duke University | Patel K.,University of Sydney | Tillmann H.L.,Duke Clinical Research Institute | And 7 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2016

Background Assessment of fibrosis progression in chronic liver disease relies upon non-invasive tools and changes in semi-quantitative histopathology scores that may not be reliable. Aim To assess the diagnostic performance of the FibroSURE (FS) index and collagen/alpha smooth muscle actin (α-SMA) morphometry in relation to longitudinal changes in fibrosis on paired biopsies. Methods The study cohort included 201 chronic hepatitis C (CHC) nonresponders enrolled in a prior phase II anti-fibrotic study. Serum FS and paired biopsies, with both collagen and α-SMA morphometry, were evaluated at baseline and week 52. Results Study patients were mostly male (67%) and Caucasian (77%), with Ishak stages 2 (n = 79), 3 (n = 88) and 4 (n = 30), excluded (n = 4 stage 1 or 5). Mean biopsy length was 22.9 mm. For baseline Ishak 2/3 vs. 4, there were no significant differences in AUROCs for collagen (0.71), SMA (0.66) or FS (0.70). At week 52, 62% of patients had no change in Ishak stage, but collagen/α-SMA increased by 34-51% (P < 0.0001), and FS decreased by 5% (P = 0.008). Among the 33% of patients with +/-1 Ishak stage change, FS changes were not significant, but α-SMA increased 29-72%, and collagen increased by 12-38% (P = 0.01 for +1 only). Conclusions Longitudinal changes in collagen and α-SMA morphometry are apparent prior to change in histological stage or FibroSURE in CHC nonresponders with intermediate fibrosis. This likely reflects quantitative morphological differences that are not detected by routine histological staging or serum markers such as FibroSURE. © 2015 John Wiley & Sons Ltd.

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