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BACKGROUND: Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19. MATERIALS AND METHODS: In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others. RESULTS: We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw. CONCLUSION: Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].
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Background and Aims: Intraoperative dexmedetomidine infusion decreases the concurrent anaesthetic and analgesic requirement. However, because of slow onset and offset, it is often used with other drugs. Opioids have a depressant effect on the cardiorespiratory system while ketamine has the opposite pharmacodynamics. Hence, it was hypothesised that ketamine will have a better intraoperative haemodynamic profile compared to fentanyl. This study compared the clinical effects and recovery characteristics of ketamine versus fentanyl when used as an adjuvant along with dexmedetomidine infusion intraoperatively. Methods: A total of 80 patients (18-60 years) undergoing major surgeries were divided into two groups: Group (D + K) received an intraoperative infusion of ketamine 0.5 mg/kg/h, while group (D + F) received fentanyl 0.5 µg/kg/h along with intravenous dexmedetomidine 0.5 µg/kg/h. Intraoperative heart rate (HR), mean blood pressure, and oxygen saturation were recorded at 0 min, 10 min of induction, and thereafter every 30 min throughout the procedure. Ramsay sedation score (RSS) and visual analogue scale (VAS) score were measured at the end of the surgery, at 2 hours, 4 hours, and 6 hours. Results: Reduction in HR and mean blood pressure was more with a tendency of developing hypotension in the fentanyl group compared to the ketamine group. Post-anaesthesia care unit (PACU) stay, need for muscle relaxant and VAS score for pain were also significantly lesser in the ketamine group. Conclusion: Dexmedetomidine with ketamine provided better haemodynamic stability and reduced PACU stay compared to dexmedetomidine with fentanyl.
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Background and Aims: To compare the sedoanalgesic effects of dexmedetomidine alone or with combination of ketamine. Material and Methods: After getting ethical approval and informed patient consent, 60 adult surgical patients, were randomly divided into two groups. Group KD (n = 30); received dexmedotomidine 0.5 µg/kg/h mixed with ketamine 0.5 µg/kg/h and Group DEX (n = 30); received dexmedotomidine at 0.5 mg/kg/h infusion only. In both the groups, study drugs were titrated (dexmedetomidine- 0.2-0.7 µg/kg/h and ketamine 0.2-0.7 mg/kg/h) to achieve target sedation. Hemodynamic variables, pain scores, sedation scores, and patient satisfaction were recorded. Qualitative and Quantitative data were analyzed with Pearson Chi-squared test and analysis of variance test, respectively. All analyses were done by using statistical package for social sciences (SPSS) version 16.0. Results: Pain scores were higher in group DEX than in group KD at 2 h and 4 h which was statistically significant (P < 0.05). At the end of 2 h, sedation scores were higher in group KD than in group DEX and was statistically significant (P < 0.05). Length of intensive care unit stay was almost comparable in both groups, and the time to tracheal extubation was lesser in ketamine-dexmedetomidine group as compared to the dexmedetomidine alone group. However the difference was statistically non-significant. Conclusions: By combining dexmedetomidine with ketamine we observed lower incidence of hypotension and bradycardia. Dexmedetomidine with ketamine combination therapy could be used safely and effectively as sedo-analgesic agent.
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BACKGROUND AND AIMS: Ventilator-associated pneumonia (VAP) is the most common healthcare-associated infection in adult critical care units. The reason behind the different levels of severity and the outcome in different individuals is not established yet.Co-morbidities and age may be a valid reason.In an attempt to find out the reason behind the different levels of severity of VAP in different individuals, we conducted a studywith the primary objective being to assess the quantitative correlation between the colony forming units (CFU) of Acinetobacter baumannii in the endotracheal tube aspirate and the Clinical Pulmonary Infection Score (CPIS) in mechanically ventilated patients without co-morbidities. The secondary objective was to see whether the severity of VAP depends on the number of CFU(>105/ml). METHODS: This observational study was conducted in a 27-bedded intensive care unit of a tertiary care hospital in northern India. Endotracheal tube aspirate was collected from patients with suspected VAP.A total of 81 patients without any prior co-morbidity and having Acinetobacter baumannii in their endotracheal tube aspirate were included in the study group. Quantification of Acinetobacter baumannii was done by counting CFU.The CPIS was calculated for all Acinetobacter baumannii positive patients. Correlation between CFU of Acinetobacter baumannii and CPIS was assessed using Spearman's Rho correlation coefficient. RESULTS: Among 81 patients having Acinetobacter baumannii infection, only 61.9% had a CPIS >4. There was an insignificant correlation between the quantity of CFUs of Acinetobacter baumannii and CPIS (P value = 0.784). CONCLUSION: Number of CFU >105/ml in an endotracheal tube aspirate culture bears no relation to the severity of VAP as predicted by the CPIS.
