Background Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials. Methods We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient’s clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death. Results A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200]. No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83 (95% confidence interval [CI], 0.52 to 1.35; P=0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of −0.46 percentage points (95% CI, −7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups. Conclusions No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo. (PlasmAr ClinicalTrials.gov number, NCT04383535 .)
Our findings indicate that there seems to be a net reabsorption of creatinine in the renal tubules of healthy old persons.
Introduction The World Health Organization (WHO) recommends vaccination against Sars Cov-2 coronavirus to mitigate COVID-19 pandemic. On December 29th, the Argentine Ministry of Health started a vaccination plan with the Sputnik V vaccine emphasizing the registration of the Events Supposedly Attributed to Vaccines and Immunizations (ESAVI) in the National Surveillance System. The aim of this study is to determine the safety of this vaccine. Methods In an ongoing cohort study, health professionals from Hospital Italiano de Buenos Aires vaccinated with the first component of the Sputnik V vaccine (a rAd26 vector-based) were followed up. Safety at 72 hs was analysed from a self-report form. Local and systemic reactions were characterized as mild, moderate and severe. Incident rates were calculated per 1000 person-hours by age groups and gender. Adjusted hazard ratio and 95% Confidence Interval (HR; 95%CI) is obtained by Cox Regression Model. Results 707 health professionals (mean age 35, 67% female) were vaccinated, response rate was 96,6% and 71,3% reported at least one ESAVI. Rate was 6.3 per 1.000 person-hours. Among local reactions, 54% reported pain at the injection site, 11% redness and swelling. Among systemic reactions 40% reported fever, 5% diarrhea and 68% new or worsened muscle pain. Five percent had serious adverse events that required medical evaluation and one inpatient. ESAVI rate was higher among females (65.4% vs 50%; HR 1.38, 95%CI 1.13-5.38) and in younger than 55 years-old (72.8% vs 32%; HR 2.66, 95%CI 1.32-1.68). Conclusion Active surveillance on safety for vaccines with emergency approval is mandatory. This study shows high rates of local and systemic reactions however early serious events were rare. Short term safety is supported by these preliminary findings. Studies on long term safety and efficacy, accoding sex and age, are needed.
Creatinine secretion pattern in very old patients with advanced chronic renal disease is similar to that observed in young ones with similar level of CKD.
Objective We evaluated the impact of an experiential learning strategy on both the adherence to the use of bundles and the incidence of ventilator-associated pneumonia in critically ill adult patients. Methods Longitudinal, quasi-experimental interrupted time-series study in a tertiary teaching hospital in Buenos Aires, Argentina. Successive measurements were made before and after the intervention was implemented between January 2016 and December 2018. Our main exposure was experiential learning, which was based on a combination of play activities, simulation models, knowledge and attitude competencies, role-playing and feedback. The adherence to the bundle for the care of mechanically ventilated critically-ill adult patients and the occurrence of ventilator-associated pneumonia were the main outcomes of interest. We used generalized linear models including time as a linear spline to estimate the effect of the experiential learning strategy both on the adherence to the bundle of care and the occurrence of ventilator-associated pneumonia during long-term follow-up. Results The overall proportion of adequate bundle use before and after the implementation of the intervention was 60.8% (95% CI: 56.9–64.7) and 85.6% (95% CI: 81.2–90.1), respectively. The incidence rate of ventilator-associated pneumonia before and after the intervention was 6.11 (95% CI: 5.82–6.40) and 3.55 (95% CI: 2.96–4.14) every 1000 days of mechanical ventilation, respectively. The estimated baseline monthly change in the adherence to the mechanical ventilation bundle was 0.4% (95%CI: −0.3–1.2%, p = 0.31) and 1.1% (95% CI: 0.2–2.2%, p < 0.01) before and after the implementation of the intervention, respectively. These results were consistent across our statistical quality control analysis. Conclusions The implementation of experiential learning strategies improves the adherence to bundles in the care of mechanically ventilated critically ill adult patients. Such strategies also decrease the incidence rate of ventilator-associated pneumonia. Both effects appear to remain constant during long-term follow-up.
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