scholarly journals Remdesivir Use and Hospital Length of Stay—The Paradox of a Clinical Trial vs Real-Life Use

2021 ◽  
Vol 4 (7) ◽  
pp. e2116057
Author(s):  
Gio J. Baracco
Keyword(s):  
Clinical Trial ◽  
Length Of Stay ◽  
Real Life ◽  
Hospital Length ◽  
Hospital Length Of Stay

scholarly journals Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial

2021 ◽  
Author(s):  
Fabio Accorsi ◽  
Jonathan Chung ◽  
Amol Mujoomdar ◽  
Daniele Wiseman ◽  
Stewart Kribs ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Length Of Stay ◽  
Point Of Care ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Human Trial ◽  
Institutional Control ◽  
Significant Difference ◽  
Registration Number ◽  
Related Mortality

Graphical abstarct Purpose To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. Methods A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE’s). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. Results All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE’s (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE’s (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE’s or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). Conclusion PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. Trial Registration Number: ClinicalTrials.gov ID NCT03575754. Graphical abstract

scholarly journals Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mehul V. Raval ◽  
Erin Wymore ◽  
Martha-Conley E. Ingram ◽  
Yao Tian ◽  
Julie K. Johnson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Length Of Stay ◽  
Enhanced Recovery ◽  
Implementation Fidelity ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Primary Study ◽  
Stepped Wedge ◽  
Cluster Randomized ◽  
Us Intervention

Abstract Background Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery. Methods The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network’s five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Discussion The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts. Trial registration ClinicalTrials.gov NCT04060303. Registered on 07 August 2019.

scholarly journals Effect of remimazolam besylate compared with propofol on the incidence of delirium after cardiac surgery: study protocol for a randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Maopeng Yang ◽  
Xinyan Liu ◽  
Daqiang Yang ◽  
Yahu Bai ◽  
Bingxin Qin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Length Of Stay ◽  
Cognitive Disorder ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background Delirium is an acute cognitive disorder that presents with fluctuation in cognition, apathy, and non-organized thinking, resulting in increased morbidity, mortality, intensive care unit (ICU) stay, and total healthcare costs. In patients undergoing cardiac surgery, delirium also increases the risk of postoperative complications, such as respiratory insufficiency, sternum instability, and need for re-operation of the sternum. This study aims to understand the incidence of delirium in patients after cardiac surgery in patients sedated with remimazolam besylate versus propofol. Methods In this prospective, double-blind, randomized controlled clinical trial, we aim to recruit 200 patients undergoing cardiac surgery between January 1, 2021, and December 31, 2021, who will be randomized to receive either remimazolam besylate or propofol infusions postoperatively, until they are extubated. The primary outcome is the incidence of delirium within 5 days after surgery. Secondary outcomes include the time of delirium onset, duration of delirium, ICU length of stay, hospital length of stay, and mechanical ventilation time. Discussion The key objective of this study is to assess whether remimazolam besylate reduces the incidence of delirium in patients after cardiac surgery compared to propofol sedation. In this preliminary randomized controlled clinical trial, we will test the hypothesis that the use of remimazolam besylate lowers the incidence of delirium when compared to propofol in patients undergoing cardiac surgery. Trial registration chictr.org.cn ChiCTR2000038976. Registered on October 11, 2020

scholarly journals 182. Missed Opportunities to Discontinue Unnecessary Vancomycin During Pharmacist Therapeutic Monitoring

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S98-S98
Author(s):  
Corey J Medler ◽  
Mary Whitney ◽  
Juan Galvan-Cruz ◽  
Ron Kendall ◽  
Rachel Kenney ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Adverse Drug Events ◽  
Academic Medical Center ◽  
Total Duration ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Therapeutic Monitoring ◽  
Resistant Bacteria ◽  
Therapeutic Drug ◽  
Missed Opportunities

Abstract Background Unnecessary and prolonged IV vancomycin exposure increases risk of adverse drug events, notably nephrotoxicity, which may result in prolonged hospital length of stay. The purpose of this study is to identify areas of improvement in antimicrobial stewardship for vancomycin appropriateness by clinical pharmacists at the time of therapeutic drug monitoring (TDM). Methods Retrospective, observational cohort study at an academic medical center and a community hospital. Inclusion: patient over 18 years, received at least three days of IV vancomycin where the clinical pharmacy TDM service assessed for appropriate continuation for hospital admission between June 19, 2019 and June 30, 2019. Exclusion: vancomycin prophylaxis or administered by routes other than IV. Primary outcome was to determine the frequency and clinical components of inappropriate vancomycin continuation at the time of TDM. Inappropriate vancomycin continuation was defined as cultures positive for methicillin-susceptible Staphylococcus aureus (MRSA), vancomycin-resistant bacteria, and non-purulent skin and soft tissue infection (SSTI) in the absence of vasopressors. Data was reported using descriptive statistics and measures of central tendency. Results 167 patients met inclusion criteria with 38.3% from the ICU. SSTIs were most common indication 39 (23.4%) cases, followed by pneumonia and blood with 34 (20.4%) cases each. At time of vancomycin TDM assessment, vancomycin continuation was appropriate 59.3% of the time. Mean of 4.22 ± 2.69 days of appropriate vancomycin use, 2.18 ± 2.47 days of inappropriate use, and total duration 5.42 ± 2.94. 16.4% patients developed an AKI. Majority of missed opportunities were attributed to non-purulent SSTI (28.2%) and missed MRSA nares swabs in 21% pneumonia cases (table 1). Conclusion Vancomycin is used extensively for empiric treatment of presumed infections. Appropriate de-escalation of vancomycin therapy is important to decrease the incidence of adverse effects, decreasing hospital length of stay, and reduce development of resistance. According to the mean duration of inappropriate therapy, there are opportunities for pharmacy and antibiotic stewardship involvement at the time of TDM to optimize patient care (table 1). Missed opportunities for vancomycin de-escalation Disclosures All Authors: No reported disclosures

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