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https://www.readbyqxmd.com/read/29326843/risk-of-acute-kidney-injury-in-patients-randomized-to-a-restrictive-versus-liberal-approach-to-red-blood-cell-transfusion-in-cardiac-surgery-a-substudy-protocol-of-the-transfusion-requirements-in-cardiac-surgery-iii-noninferiority-trial
#1
Amit X Garg, Nadine Shehata, Shay McGuinness, Richard Whitlock, Dean Fergusson, Ron Wald, Chirag Parikh, Sean M Bagshaw, Boris Khanykin, Alex Gregory, Summer Syed, Gregory M T Hare, Meaghan S Cuerden, Kevin E Thorpe, Judith Hall, Subodh Verma, Pavel S Roshanov, Jessica M Sontrop, C David Mazer
Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion...
2018: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/29310868/high-velocity-nasal-insufflation-in-the-treatment-of-respiratory-failure-a-randomized-clinical-trial
#2
Pratik Doshi, Jessica S Whittle, Michael Bublewicz, Joseph Kearney, Terrell Ashe, Russell Graham, Suesann Salazar, Terry W Ellis, Dianna Maynard, Rose Dennis, April Tillotson, Mandy Hill, Misha Granado, Nancy Gordon, Charles Dunlap, Sheldon Spivey, Thomas L Miller
STUDY OBJECTIVE: We compare high-velocity nasal insufflation, a form of high-flow nasal cannula, with noninvasive positive-pressure ventilation in the treatment of undifferentiated respiratory failure with respect to therapy failure, as indicated by requirement for endotracheal intubation or cross over to the alternative therapy. METHODS: This was a multicenter, randomized trial of adults presenting to the emergency department (ED) with respiratory failure requiring noninvasive positive-pressure ventilation...
January 5, 2018: Annals of Emergency Medicine
https://www.readbyqxmd.com/read/29310376/perioperative-analgesia-after-intrathecal-fentanyl-and-morphine-or-morphine-alone-for-cesarean-section-a-randomized-controlled-study
#3
Wojciech Weigl, Andrzej Bieryło, Monika Wielgus, Świetlana Krzemień-Wiczyńska, Marcin Kołacz, Michał J Dąbrowski
OBJECTIVES: Intrathecal morphine is used in the postoperative management of pain after caesarean section (CS), but might not be optimal for intraoperative analgesia. We hypothesized that intrathecal fentanyl could supplement intraoperative analgesia when added to a local anesthetic and morphine without affecting management of postoperative pain. METHODS: This prospective, randomized, double-blind, parallel-group study included 60 parturients scheduled for elective CS...
December 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29301713/the-coronary-artery-disease-reporting-and-data-system-cad-rads-prognostic-and-clinical-implications-associated-with-standardized-coronary-computed-tomography-angiography-reporting
#4
Joe X Xie, Ricardo C Cury, Jonathon Leipsic, Matthew T Crim, Daniel S Berman, Heidi Gransar, Matthew J Budoff, Stephan Achenbach, Bríain Ó Hartaigh, Tracy Q Callister, Hugo Marques, Ronen Rubinshtein, Mouaz H Al-Mallah, Daniele Andreini, Gianluca Pontone, Filippo Cademartiri, Erica Maffei, Kavitha Chinnaiyan, Gilbert Raff, Martin Hadamitzky, Joerg Hausleiter, Gudrun Feuchtner, Allison Dunning, Augustin DeLago, Yong-Jin Kim, Philipp A Kaufmann, Todd C Villines, Benjamin J W Chow, Niree Hindoyan, Millie Gomez, Fay Y Lin, Erica Jones, James K Min, Leslee J Shaw
OBJECTIVES: This study sought to assess clinical outcomes associated with the novel Coronary Artery Disease-Reporting and Data System (CAD-RADS) scores used to standardize coronary computed tomography angiography (CTA) reporting and their potential utility in guiding post-coronary CTA care. BACKGROUND: Clinical decision support is a major focus of health care policies aimed at improving guideline-directed care. Recently, CAD-RADS was developed to standardize coronary CTA reporting and includes clinical recommendations to facilitate patient management after coronary CTA...
January 2018: JACC. Cardiovascular Imaging
https://www.readbyqxmd.com/read/29301640/1-year-clinical-outcomes-in-women-after-transcatheter-aortic-valve-replacement-results-from-the-first-win-tavi-registry
#5
Alaide Chieffo, Anna Sonia Petronio, Julinda Mehilli, Jaya Chandrasekhar, Samantha Sartori, Thierry Lefèvre, Patrizia Presbitero, Piera Capranzano, Didier Tchetche, Alessandro Iadanza, Gennaro Sardella, Nicolas M Van Mieghem, Emanuele Meliga, Nicholas Dumonteil, Chiara Fraccaro, Daniela Trabattoni, Ghada Mikhail, Samin Sharma, Maria Cruz Ferrer, Christoph Naber, Peter Kievit, Usman Baber, Clayton Snyder, Madhav Sharma, Marie Claude Morice, Roxana Mehran
OBJECTIVES: This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes. BACKGROUND: Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex...
January 8, 2018: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29298407/a-hybrid-form-of-telemedicine-a-unique-way-to-extend-intensive-care-service-to-neonates-in-medically-underserved-areas
#6
Abhishek Makkar, Mike McCoy, Gene Hallford, Marilyn Escobedo, Edgardo Szyld
BACKGROUND: More than 90% of neonatal intensive care units (NICUs) in the United States are in urban areas, denying rural residents' easy NICU access. Telemedicine use for patient contact and management, although studied in adults and children, is understudied in neonates. A hybrid telemedicine system, with 24/7 neonatal nurse practitioner coverage and with a neonatologist physically present 3 days per week and telemedicine coverage the remaining days, was recently implemented at Comanche County Memorial Hospital's (CCMH) Level II NICU...
January 3, 2018: Telemedicine Journal and E-health: the Official Journal of the American Telemedicine Association
https://www.readbyqxmd.com/read/29297076/effect-of-mechanically-expanded-vs-self-expanding-transcatheter-aortic-valve-replacement-on-mortality-and-major-adverse-clinical-events-in-high-risk-patients-with-aortic-stenosis-the-reprise-iii-randomized-clinical-trial
#7
Ted E Feldman, Michael J Reardon, Vivek Rajagopal, Raj R Makkar, Tanvir K Bajwa, Neal S Kleiman, Axel Linke, Dean J Kereiakes, Ron Waksman, Vinod H Thourani, Robert C Stoler, Gregory J Mishkel, David G Rizik, Vijay S Iyer, Thomas G Gleason, Didier Tchétché, Joshua D Rovin, Maurice Buchbinder, Ian T Meredith, Matthias Götberg, Henrik Bjursten, Christopher Meduri, Michael H Salinger, Dominic J Allocco, Keith D Dawkins
Importance: Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants: The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017...
January 2, 2018: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29296999/safety-and-efficacy-of-a-3-dimensional-stent-retriever-with-aspiration-based-thrombectomy-vs-aspiration-based-thrombectomy-alone-in-acute-ischemic-stroke-intervention-a-randomized-clinical-trial
#8
Raul G Nogueira, Donald Frei, Jawad F Kirmani, Osama Zaidat, Demetrius Lopes, Aquilla S Turk, Donald Heck, Brian Mason, Diogo C Haussen, Elad I Levy, Siddhart Mehta, Marc Lazzaro, Michael Chen, Arnd Dörfler, Albert J Yoo, Colin P Derdeyn, Lee Schwamm, David Langer, Adnan Siddiqui
Importance: The treatment effects of individual mechanical thrombectomy devices in large-vessel acute ischemic stroke (AIS) remain unclear. Objective: To determine whether the novel 3-dimensional (3-D) stent retriever used in conjunction with an aspiration-based mechanical thrombectomy device (Penumbra System; Penumbra) is noninferior to aspiration-based thrombectomy alone in AIS. Design, Setting, and Participants: This randomized, noninferiority clinical trial enrolled patients at 25 North American centers from May 19, 2012, through November 19, 2015, with follow-up for 90 days...
January 2, 2018: JAMA Neurology
https://www.readbyqxmd.com/read/29289540/a-randomized-controlled-study-comparing-a-dpp4-inhibitor-linagliptin-and-basal-insulin-glargine-in-patients-with-type-2-diabetes-in-long-term-care-and-skilled-nursing-facilities-linagliptin-ltc-trial
#9
Guillermo E Umpierrez, Saumeth Cardona, David Chachkhiani, Maya Fayfman, Sahebi Saiyed, Heqiong Wang, Priyathama Vellanki, J Sonya Haw, Darin E Olson, Francisco J Pasquel, Theodore M Johnson
OBJECTIVES: Safe and easily implemented treatment regimens are needed for the management of patients with type 2 diabetes mellitus (T2DM) in long-term care (LTC) and skilled nursing facilities. DESIGN: This 6-month open-label randomized controlled trial compared the efficacy and safety of a DPP4 inhibitor (linagliptin) and basal insulin (glargine) in LTC residents with T2DM. SETTINGS: Three LTC institutions affiliated with a community safety-net hospital, US Department of Veterans Affairs and Emory Healthcare System in Atlanta, Georgia...
December 27, 2017: Journal of the American Medical Directors Association
https://www.readbyqxmd.com/read/29289383/immunogenicity-of-a-two-dose-investigational-hepatitis-b-vaccine-hbsag-1018-using-a-toll-like-receptor-9-agonist-adjuvant-compared-with-a-licensed-hepatitis-b-vaccine-in-adults
#10
Sam Jackson, Joseph Lentino, James Kopp, Linda Murray, William Ellison, Margaret Rhee, Gerald Shockey, Lalith Akella, Kimberly Erby, William L Heyward, Robert S Janssen
BACKGROUND: Hepatitis B virus infection remains an important public health problem in the United States. Currently approved alum-adjuvanted vaccines require three doses and have reduced immunogenicity in adults, particularly in those who have diabetes mellitus, or are older, male, obese, or who smoke. METHODS: Phase 3 observer-blinded, randomized (2:1 HBsAg-1018 [HEPLISAV-B™]:HBsAg-Eng [Engerix-B®]), active-controlled trial in adults 18-70 years of age. HBsAg-1018 was administered intramuscularly at weeks 0 and 4 and placebo at week 24 and HBsAg-Eng at weeks 0, 4, and 24...
December 27, 2017: Vaccine
https://www.readbyqxmd.com/read/29284503/bronchoscopy-versus-an-endotracheal-tube-mounted-camera-for-the-peri-interventional-visualization-of-percutaneous-dilatational-tracheostomy-a-prospective-randomized-trial-vivapdt
#11
Jörn Grensemann, Lars Eichler, Sophie Kähler, Dominik Jarczak, Marcel Simon, Hans O Pinnschmidt, Stefan Kluge
BACKGROUND: Percutaneous dilatational tracheostomy (PDT) in critically ill patients often involves bronchoscopic optical guidance. However, this procedure is not without disadvantages. Therefore, we aimed to study a recently introduced endotracheal tube-mounted camera (VivaSightTM-SL tube [VST]; ETView, Misgav, Israel) for guiding PDT. METHODS: This was a randomized controlled trial involving 46 critically ill patients who received PDT using optical guidance with a VST or with bronchoscopy...
December 29, 2017: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/29283952/is-there-still-a-role-for-vancomycin-in-skin-and-soft-tissue-infections
#12
Alessia Savoldi, Anna M Azzini, David Baur, Evelina Tacconelli
PURPOSE OF REVIEW: Skin and soft-tissue infections (SSIs) are among the commonest infections encountered in clinical practice. Spread of methicillin-resistant Staphylococcus aureus SSIs continues to increase in both health care and community settings and presents a challenge for the best treatment choice. Vancomycin has been the mainstay of SSIs treatment, but recently its use has been questioned because of concerns about its efficacy, tolerability, and unfavorable pharmacokinetic/pharmacodynamic profile...
December 27, 2017: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/29283133/use-and-validation-of-mirrorless-digital-single-light-reflex-camera-for-recording-of-vitreoretinal-surgeries-in-high-definition
#13
Sumeet Khanduja, Raju Sampangi, B C Hemlatha, Satvir Singh, Ashish Lall
PURPOSE: The purpose of this study is to describe the use of commercial digital single light reflex (DSLR) for vitreoretinal surgery recording and compare it to standard 3-chip charged coupling device (CCD) camera. METHODS: Simultaneous recording was done using Sony A7s2 camera and Sony high-definition 3-chip camera attached to each side of the microscope. The videos recorded from both the camera systems were edited and sequences of similar time frames were selected...
January 2018: Indian Journal of Ophthalmology
https://www.readbyqxmd.com/read/29282862/use-of-a-historical-control-group-in-a-noninferiority-trial-assessing-a-new-antibacterial-treatment-a-case-study-and-discussion-of-practical-implementation-aspects
#14
David Dejardin, Paul Delmar, Charles Warne, Katie Patel, Joost van Rosmalen, Emmanuel Lesaffre
When recruitment into a clinical trial is limited due to rarity of the disease of interest, or when recruitment to the control arm is limited due to ethical reasons (eg, pediatric studies or important unmet medical need), exploiting historical controls to augment the prospectively collected database can be an attractive option. Statistical methods for combining historical data with randomized data, while accounting for the incompatibility between the two, have been recently proposed and remain an active field of research...
December 28, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29281119/gestational-weight-gain-for-gestational-age-z-score-charts-applied-across-u-s-populations
#15
Stephanie A Leonard, Jennifer A Hutcheon, Lisa M Bodnar, Lucia C Petito, Barbara Abrams
BACKGROUND: Gestational weight gain may be a modifiable contributor to infant health outcomes, but the effect of gestational duration on gestational weight gain has limited the identification of optimal weight gain ranges. Recently developed z-score and percentile charts can be used to classify gestational weight gain independent of gestational duration. However, racial/ethnic variation in gestational weight gain and the possibility that optimal weight gain differs among racial/ethnic groups could affect generalizability of the z-score charts...
December 27, 2017: Paediatric and Perinatal Epidemiology
https://www.readbyqxmd.com/read/29281036/a-phase-3-randomized-double-blind-multicenter-study-to-evaluate-the-safety-and-efficacy-of-intravenous-iclaprim-vs-vancomycin-for-the-treatment-of-acute-bacterial-skin-and-skin-structure-infections-suspected-or-confirmed-to-be-due-to-gram-positive-pathogens
#16
David B Huang, William O'Riordan, J Scott Overcash, Barry Heller, Faisal Amin, Thomas M File, Mark H Wilcox, Antoni Torres, Matthew Dryden, Thomas L Holland, Patrick McLeroth, Rajesh Shukla, G Ralph Corey
Background: Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). Methods: REVIVE-1 was a phase 3, 600-patient, double-blinded, randomized (1:1), active-controlled trial among patients with ABSSSI that compared the safety and efficacy of iclaprim 80 mg fixed dose with vancomycin 15 mg/kg, both administered intravenously every 12 hours for 5-14 days...
December 21, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29276013/outcome-of-secondary-stroke-prevention-in-patients-taking-non-vitamin-k-antagonist-oral-anticoagulants
#17
Taizen Nakase, Junta Moroi, Tatsuya Ishikawa
BACKGROUND: Since non-vitamin K antagonist oral anticoagulants (NOACs) were released for clinical use, many studies have investigated its effectiveness in stroke prevention. In this study, to determine whether or not there is a difference in outcome in secondary stroke prevention between warfarin and NOACs, patients with embolic stroke with newly prescribed anticoagulants were prospectively analyzed. METHODS: Patients with acute ischemic stroke, who newly started anticoagulant therapy, were consecutively asked to participate in this study...
December 21, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/29273477/transfusion-requirements-in-cardiac-surgery-iii-trics-iii-study-design-of-a-randomized-controlled-trial
#18
Nadine Shehata, Richard Whitlock, Dean A Fergusson, Kevin E Thorpe, Charlie MacAdams, Hilary P Grocott, Fraser Rubens, Stephen Fremes, Francois Lellouche, Sean Bagshaw, Alistair Royse, Peter M Rosseel, Greg Hare, Etienne De Medicis, Christopher Hudson, Emilie Belley-Cote, Daniel Bainbridge, Blaine Kent, Andrew Shaw, Kelly Byrne, Summer Syed, Colin F Royse, Shay McGuiness, Judith Hall, C David Mazer
OBJECTIVES: To determine if a restrictive transfusion threshold is noninferior to a higher threshold as measured by a composite outcome of mortality and serious morbidity. DESIGN: Transfusion Requirements in Cardiac Surgery (TRICS) III was a multicenter, international, open-label randomized controlled trial of two commonly used transfusion strategies in patients having cardiac surgery using a noninferiority trial design (ClinicalTrials.gov number, NCT02042898). SETTING: Eligible patients were randomized prior to surgery in a 1:1 ratio...
November 3, 2017: Journal of Cardiothoracic and Vascular Anesthesia
https://www.readbyqxmd.com/read/29261354/prospective-comparison-of-standard-versus-low-radiation-dose-ct-enterography-for-the-quantitative-assessment-of-crohn-disease
#19
Greg Rosenfeld, Jacqueline Brown, Patrick M Vos, Jonathon Leipsic, Robert Enns, Brian Bressler
OBJECTIVE: CT enterography (CTE) is sensitive and specific for active inflammatory changes of Crohn disease (CD), but its use has been limited by exposure to ionizing radiation. The objective of this study is to show the noninferiority of a model-based iterative reconstruction (MBIR) technique using lower radiation doses compared with standard-dose CTE in the assessment of CD. SUBJECTS AND METHODS: Patients referred to a hospital radiology department for CTE for the evaluation of CD underwent both a standard examination (used to generate filtered back-projection and adaptive statistical iterative reconstruction [ASIR] images) and low-dose MBIR CTE performed in a random sequence on the same day...
December 20, 2017: AJR. American Journal of Roentgenology
https://www.readbyqxmd.com/read/29260952/difluprednate-0-05-versus-prednisolone-acetate-1-for-endogenous-anterior-uveitis-pooled-efficacy-analysis-of-two-phase-3-studies
#20
John D Sheppard, C Stephen Foster, Melissa M Toyos, Kerry Markwardt, Robert Da Vanzo, Thomas E Flynn, John H Kempen
PURPOSE: To analyse pooled data from 2 similar phase 3 noninferiority studies comparing difluprednate 0.05% versus prednisolone acetate 1% in patients with endogenous anterior uveitis. METHODS: Patients received difluprednate alternating with vehicle or prednisolone acetate for 14 days (8 drops/day in both groups), followed by tapering from day 14 to 28. All patients were observed until day 42. RESULTS: More patients on difluprednate than on prednisolone acetate were cleared of anterior chamber cells on day twenty one (71...
December 20, 2017: Ocular Immunology and Inflammation
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