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Author(s):  
Mary Beth Wire ◽  
Soo Youn Jun ◽  
In-Jin Jang ◽  
Seung-Hwan Lee ◽  
Jun Gi Hwang ◽  
...  

Thirty-two healthy male subjects (8 per cohort) were randomized 6:2 to active:placebo. LSVT-1701, an anti-staphylococcal lysin, was administered intravenously as a 6 mg/kg single dose and as 1.5, 3, and 4.5 mg/kg twice daily for 4 days. LSVT-1701 exposure increased in a greater than dose proportional manner and did not accumulate. Treatment-emergent adverse events (TEAEs) were predominantly of mild intensity. The most common TEAEs were chills, pyrexia, headache, infusion site events, cough, rhinorrhea, and increases in C-reactive protein.


2021 ◽  
Vol 4 (1) ◽  
pp. 1-7
Author(s):  
Kuat Sitepu ◽  
Anita Srigandaria Purba ◽  
Arfah May Sara ◽  
Widya .

Background :  The incidence of ebitis is one indicator of the quality of hospital services with the standard set by The Infusion Nursing of Practice, which is 5%. The incidence of phlebitis is an indicator of minimum hospital service quality with a standard incidence of ≤1.5%. Purpose : Knowing the effect of using betadine ointment on the incidence of phlebitis at the intravenous infusion site at the Army Hospital TK IV. 01.07.01 Pematangsiantar. Methods : This type of research the researcher used was a quasi experiment with the equivalent control group design. The research instrument used was an observation sheet with a sample of 30 patients who had an intravenous infusion attached. Results: There was a significant effect of using betadine ointment on the incidence of phlebitis on intravenous infusion therapy. Statistical analysis using normality test, homogeneity and hypothesis testing. Conclusions and suggestions : The use of betadine ointment against the incidence of phlebitis at the intravenous infusion site has a significant relationship. Therefore the hospital management must continue to make efforts to improve services to patients. As a suggestion, room nurses should increase their knowledge through training on infection control and prevention, nosocomial infection prevention training in hospitals.


Author(s):  
Shereen Kesserwan ◽  
Li Mao ◽  
Roshanak Sharafieh ◽  
Donald L. Kreutzer ◽  
Ulrike Klueh

2021 ◽  
pp. 089719002110383
Author(s):  
Michael J. Corrado ◽  
Andrew Riselli ◽  
Kevin C. McLaughlin ◽  
Paul M. Szumita ◽  
Kevin E. Anger

Background: Recent shortages of intravenous (IV) fluids have resulted in healthcare systems converting administration of many medications from IV piggyback (IVPB) to IV push (IVP). Administering medications via IVP presents numerous advantages; however, IV site reactions such as phlebitis and infiltration may occur. Objective: The objective of this analysis is to evaluate the infusion site safety of ertapenem given as peripheral IVP compared to IVPB in adult patients. Methods: This was an institutional review board–approved, single-center, retrospective study. Patients, ages 18 or older, receiving IV ertapenem were identified. The major endpoints analyzed were IV site reactions including phlebitis and infiltration. The Naranjo Nomogram was utilized to assess the causality of the reactions to determine the likelihood of whether the event was caused by the medication itself or other factors. Results: To date, 283 administrations (92 patients) in the IVP group and 319 administrations (82 patients) in the IVPB group were analyzed. There were 13 IV site reactions compared to 8 in the IVP vs IVPB group, respectively ( P-value = 0.16). Ten of the events in the IVP group were deemed “possible” and 2 deemed “doubtful,” while the remaining event was considered “probable” per the Naranjo Nomogram. Of the events in the IVPB group, all 8 were found to be “possible.” Conclusion: The administration of IVP ertapenem showed comparable rates of infusion site reactions compared to IVPB. Implementation of IVP ertapenem appears to be associated with infusion site safety similar to IVPB and should be considered safe to administer.


BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S289-S289
Author(s):  
Harriet Sharp ◽  
Alfonso Russo ◽  
Alessandro Colasanti ◽  
Antonello Pinna ◽  
Prince Nwaubani ◽  
...  

AimsTo summarise the tolerability profile following an infusion of methylene blue (MB), including subjective effects on mood and energy levels and haemodynamic changes, in patients with Bipolar Affective Disorder (BPAD).BackgroundBPAD is associated with mitochondrial dysfunction and impaired cellular energy production. MB is proposed to enhance mitochondria function via rerouting electrons and intracellular reduction of oxidative stress, and is therefore a candidate compound for use as a probe to reveal alterations in brain oxygen metabolism in vivo in patients with BPAD. Although there are reports of MB used as treatment for BPAD, the tolerability and subjective effects of a single IV dose in this population has not yet been defined.MethodUsing a single-blind, randomised, within-subject design, 7 patients with BPAD on stable pharmacological treatment and 6 healthy controls (HCs) received an infusion of 0.5mg/kg MB and a placebo glucose solution one week apart. Visual Analogue Scales (VAS) assessing ‘Mood’ and ‘Energy’ levels were completed by 11 participants, and blood pressure (BP), heart rate (HR) and any subsequent side effects were recorded before and after infusions.ResultA significant, albeit very small, effect of MB on ‘Mood’ levels relative to placebo was demonstrated, independent of groups (change relative to baseline: 5.5% ± 11 increase (placebo) vs -1.6 % ± 9.5 reduction (MB); p = 0.027). Although there was no effect of MB on energy levels in either group, there appeared to be a trend for a general group difference in ‘Energy’ levels across all trials, with lower ratings in BPAD patients (p = 0.058).There was a trend for significantly lower post-infusion HR relative to pre-infusion (-6.4 ± 8.8 bpm, p = 0.07. Diastolic BP was higher (3.0 ± 7.8mmHg, p = 0.039). These effects were independent of groups and drug. The most common side effect with MB was mild/moderate pain at infusion site (n = 10/13), resolving within median 32.5 minutes (IQR 6-102), and discoloured urine in 7/13 subjects lasting median 44.5 hours (IQR 36-59). No difference in frequency of side effects reported between groups.ConclusionAlthough limited by small sample size, this tolerability analysis demonstrates a acceptable profile of effects of MB on subjective ratings and blood pressure, in both BPAD and HCs. Common side effects of discoloured urine and pain at infusion site are in line with previous reports in the literature. We observed a small effect of MB on mood ratings which could be related to the discomfort experienced during infusion.


Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 104-LB
Author(s):  
DEBRA A. IGNAUT ◽  
JANG IK CHO ◽  
JOHN C. ELPERS ◽  
FARAI B. CHIGUTSA ◽  
CAROLINA PIRAS DE OLIVEIRA

2021 ◽  
Author(s):  
Anastasia S Lambrou ◽  
John T Redd ◽  
Miles A Stewart ◽  
Kaitlin Rainwater-Lovett ◽  
Jonathan K Thornhill ◽  
...  

Background: The COVID-19 pandemic caught the globe unprepared without targeted medical countermeasures, such as therapeutics, to target the emerging SARS-CoV-2 virus. However, in recent months multiple monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). Despite these authorizations and promising clinical trial efficacy results, monoclonal antibody therapies are currently underutilized as a treatment for COVID-19 across the U.S. Many barriers exist when deploying a new infused therapeutic during an ongoing pandemic with limited resources and staffing, and it is critical to better understand the process and site requirements of incorporating monoclonal antibody infusions into pandemic response activities. Methods: We examined the monoclonal antibody infusion site process components, resources, and requirements during the COVID-19 pandemic using data from three initial infusion sites at medical centers in the U.S. supported by the National Disaster Medical System. A descriptive analysis was conducted using process assessment metrics to inform recommendations to strengthen monoclonal antibody infusion site implementation. Results: The monoclonal antibody infusion sites varied in physical environment and staffing models due to state polices, infection control mechanisms, and underlying medical system structure, but exhibited a common process workflow. Sites operationalized an infusion process staffing model with at least two nurses per ten infusion patients. Monoclonal antibody implementation success factors included tailoring the infusion process to the patient community, strong engagement with local medical providers, batch preparing the therapy before patient arrival, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges stemmed from confirming patient SARS-CoV-2 positivity, strained staff, scheduling needs, and coordination with the pharmacy for therapy preparation. Conclusions: Infusion site processes are most effective when integrated into the pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources. As the pandemic and policy tools such as EUAs evolve, monoclonal antibody infusion processes must also remain adaptable, as practice changes directly affect resources, staffing, timing, and workflows. Future use may be aided by incorporating innovative emergency deployment techniques, such as vehicle and home-based therapy administration, and by developing drug delivery mechanisms that alleviate the need for observed intravenous infusions by medically-accredited staff.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Timothy R. Smith ◽  
Egilius L. H. Spierings ◽  
Roger Cady ◽  
Joe Hirman ◽  
Barbara Schaeffler ◽  
...  

Abstract Background The humanized anti-CGRP monoclonal antibody eptinezumab has been evaluated in five large-scale clinical trials conducted in patients with migraine. This integrated analysis was conducted to evaluate the comprehensive safety and tolerability of eptinezumab in patients with migraine across these studies. Methods Data were pooled from four randomized, double-blind, placebo-controlled studies and the first year of one open-label study. Results The pooled population comprised 2867 adults with migraine: eptinezumab, n = 2076 (4797 infusions); placebo, n = 791 (1675 infusions). A total of 1137/2076 (54.8%) patients who received eptinezumab and 414/791 (52.3%) patients who received placebo experienced ≥1 treatment-emergent adverse event (TEAE); rates were similar across eptinezumab dose groups (10–1000 mg). For most patients with TEAEs, the events were mild or moderate in severity and considered unrelated to study drug by the investigators. Thirty infusion-site AEs occurred in 27/2076 (1.3%) patients who received eptinezumab and 7 in 7/791 (0.9%) patients who received placebo. Infusion-site AEs led to infusion interruption in 19/2076 (0.9%) and 5/791 (0.6%) patients in the eptinezumab and placebo groups, respectively. Nasopharyngitis occurred in ≥2% of patients in the eptinezumab 300-mg group and with an incidence of at least 2 percentage points greater than in the placebo group; however, in most patients (eptinezumab, 139/140; placebo 40/41), its occurrence was considered not related to study treatment. Adverse events coded to hypersensitivity occurred for 23/2076 (1.1%) patients treated with eptinezumab and no patients in the placebo group. If additional TEAE terms that could indicate hypersensitivity are considered (e.g., urticaria, flushing/hot flush, rash, and pruritus), hypersensitivity reactions in the two pivotal placebo-controlled phase 3 studies occurred in ≥2% of patients in the eptinezumab 100-mg and 300-mg groups, and the incidence was at least 2 percentage points greater in either of these groups than in the placebo group. Most hypersensitivity reactions were not serious and resolved with standard medical treatment or observation without treatment, usually within 1 day. Conclusions In adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile. Trial registration ClinicalTrials.gov (Identifiers: NCT01772524, NCT02275117, NCT02559895, NCT02974153, NCT02985398).


2021 ◽  
pp. 193229682199785
Author(s):  
Lorenzo Meneghetti ◽  
Eyal Dassau ◽  
Francis J. Doyle ◽  
Simone Del Favero

Background: Personal insulin pumps have shown to be effective in improving the quality of therapy for people with type 1 diabetes (T1D). However, the safety of this technology is limited by the possible infusion site failures, which are linked with hyperglycemia and ketoacidosis. Thanks to the large availability of collected data provided by modern therapeutic technologies, machine learning algorithms have the potential to provide new way to identify failures early and avert adverse events. Methods: A clinical dataset ( N = 20) is used to evaluate a novel method for detecting real-time infusion site failures using unsupervised anomaly detection algorithms, previously proposed and developed on in-silico data. An adapted feature engineering procedure is introduced to make the method able to operate in the absence of a closed-loop (CL) system and meal announcements. Results: In the optimal configuration, we obtained a performance of 0.75 Sensitivity (15 out of 20 total failures detected) and 0.08 FP/day, outperforming previously proposed literature algorithms. The algorithm was able to anticipate the replacement of the malfunctioning infusion sets by ~2 h on average. Conclusions: On the considered dataset, the proposed algorithm showed the potential to improve the safety of patients treated with sensor-augmented pump systems.


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