Since the beginning of the COVID-19 pandemic, great hesitancies regarding the COVID-19 immunization have existed. The most striking adverse events reported include thrombosis with thrombocytopenia ...syndrome (TTS), myocarditis, and Guillain Barre Syndrome (GBS). Post-vaccination GBS is known since the time of Influenza vaccination, but several cases of GBS have also been reported in the current COVID-19 vaccination era. As a result, our patient with a history of GBS post-Influenza vaccination, went unvaccinated for SARS-CoV-2, due to fear of GBS re-activation. Consequently, he contracted COVID-19 pneumonitis complicated with deep venous thrombosis, requiring a prolonged hospitalization. Weighing the risks and benefits of vaccination to COVID-19 is difficult, especially for people with a previous history of GBS related to Influenza vaccination. We reviewed and analyzed the reported cases of GBS temporary related to COVID-19 vaccination to determine the safety of their administration in those with a history of GBS.
BACKGROUNDLimited data is available on the incidence and outcomes of pneumothorax (PTX), pneumomediastinum (PNM), and subcutaneous emphysema (SCE) in COVID-19 patients. This study aimed to ...investigate the characteristics of these complications in hospitalized COVID-19 patients.RESEARCH DESIGN AND METHODSA retrospective study was conducted, involving adult COVID-19 patients admitted to Mayo Clinic Florida from 03/2020-06/2022. Patients were divided into two groups based on the presence or absence of PTX/PNM/SCE.RESULTS1926 hospitalized patients with COVID-19 were included, of which 518 were admitted to the ICU. The incidence of PTX/PNM/SCE was 6.3%. Patients with these complications were more likely to be male, Asian, and unvaccinated. Conversely, they were less likely to have chronic obstructive pulmonary disease. Patients who developed PTX/PNM/SCE after 72 hours of admission were more likely to receive high-dose corticosteroids and for an extended duration. The affected group had an adjusted odds ratio for in-hospital mortality of 13.32 (95%CI, 8.19-21.59) and ICU admission of 9.14 (95%CI, 5.3-12.78) compared to the unaffected group.CONCLUSIONAlthough the occurrence of PTX/PNM/SCE in hospitalized COVID-19 patients was rare, it was associated with worse outcomes. Corticosteroids may contribute to the pathogenesis of these complications; however, further studies are needed to investigate this relationship in more detail.
A multicenter, randomized trial involving participants with diabetes and no evident cardiovascular disease at trial entry showed that aspirin led to a lower risk of serious vascular events than ...placebo but also caused a higher risk of major bleeding.
In this trial involving patients with diabetes without evidence of cardiovascular disease, the risk of serious vascular events was similar in those who received n−3 fatty acid supplements and those ...who received placebo.
The Surviving Sepsis Campaign suggested preferential resuscitation with balanced crystalloids, such as Lactated Ringer's (LR), although the level of recommendation was weak, and the quality of ...evidence was low. Past studies reported an association of unbalanced solutions, such as normal saline (NS), with increased AKI risks, metabolic acidosis, and prolonged ICU stay, although some of the findings are conflicting. We have compared the outcomes with the preferential use of normal saline vs. ringer's lactate in a cohort of sepsis patients.
We performed a retrospective cohort analysis of patients visiting the ED of 19 different Mayo Clinic sites between August 2018 to November 2020 with sepsis and receiving at least 30 mL/kg fluid in the first 6 h. Patients were divided into two cohorts based on the type of resuscitation fluid (LR vs. NS) and propensity-matching was done based on clinical characteristics as well as fluid amount (with 5 ml/kg). Single variable logistic regression (categorical outcomes) and Cox proportional hazards regression models were used to compare the primary and secondary outcomes between the 2 groups.
Out of 2022 patients meeting our inclusion criteria; 1,428 (70.6%) received NS, and 594 (29.4%) received LR as the predominant fluid (>30 mL/kg). Patients receiving predominantly NS were more likely to be male and older in age. The LR cohort had a higher BMI, lactate level and incidence of septic shock. Propensity-matched analysis did not show a difference in 30-day and in-hospital mortality rate, mechanical ventilation, oxygen therapy, or CRRT requirement. We did observe longer hospital LOS in the LR group (median 5 vs. 4 days,
= 0.047 and higher requirement for ICU post-admission (OR: 0.70; 95% CI: 0.51-0.96;
= 0.026) in the NS group. However, these did not remain statistically significant after adjustment for multiple testing.
In our matched cohort, we did not show any statistically significant difference in mortality rates, hospital LOS, ICU admission after diagnosis, mechanical ventilation, oxygen therapy and RRT between sepsis patients receiving lactated ringers and normal saline as predominant resuscitation fluid. Further large-scale prospective studies are needed to solidify the current guidelines on the use of balanced crystalloids.
Clinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN ...Diabetes) is a randomised '2 × 2 factorial design' study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data.
Information on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised.
If sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively.
Current Controlled Trials, ISRCTN60635500 , registered on 14 July 2005.