Background We designed this single-centre clinical trial to assess the potential benefits of N-Acetylcysteine (NAC) in patients with COVID19-associated acute respiratory distress syndrome (ARDS). Methods Ninety-two patients with mild-to-moderate COVID19-associated ARDS were allocated to the placebo (45-cases) or NAC groups (47-cases). Besides standard-of-care treatment, the patients received either intravenous NAC at a dose of 40 mg/kg/day or the placebo for three consecutive days. The efficacy outcomes were overall mortality over 28-day, clinical status on day 28, based on the WHO Master Protocol, the proportion of patients requiring mechanical ventilation, changes in ARDS-severity (based on the PaO 2 /FiO 2 ratio), and Sequential Organ Failure Assessment (SOFA) scores 48 and 96 h after intervention, Results No differences were found in the 28-day mortality rate between the two groups (25.5% vs. 31.1% in the NAC and placebo groups, respectively). Although the distribution of the clinical status at day 28 shifted towards better outcomes in the NAC-treated group, it did not reach a statistical significance level (p value = 0.83). Similar results were achieved in terms of the proportion of patients who required invasive ventilator support (38.3% vs. 44.4%), the number of ventilator-free days (17.4 vs. 16.6), and median time of ICU and hospital stay. Results regarding the change in PaO 2 /FiO 2 ratio and SOFA scores also showed no significant differences between the groups. Conclusions Our pilot study did not support the potential benefits of intravenous NAC in treating patients with COVID-19-associated ARDS. More studies are needed to determine which COVID-19 patients benefit from the NAC administration. Trial registration The trial was registered at Clinicaltrials.gov (identifier code: IRCT20120215009014N355). Registration date: 2020-05-18.
Background
This prospective controlled clinical trial aimed to compare the efficacy of methylprednisolone, dexamethasone, and hydrocortisone at equivalent doses in patients with severe COVID-19.
Methods
In total, 106 patients with mild to moderate COVID-19-related acute respiratory distress syndrome (ARDS) were randomized to receive either dexamethasone (6 mg once a day), methylprednisolone (16 mg twice a day), or hydrocortisone (50 mg thrice a day) for up to 10 days. All participants received a standard of care for COVID-19. The primary and secondary efficacy outcomes included all-cause 28-day mortality, clinical status on day 28 assessed using the World Health Organization (WHO) eight-category ordinal clinical scale, number of patients requiring mechanical ventilation and intensive care unit (ICU) care, number of ventilator-free days, length of hospital and ICU stay, change in PaO
2
:FiO
2
ratios during the first 5 days after treatment, and incidence of serious adverse events.
P
-values below 0.008 based on Bonferroni’s multiple-testing correction method were considered statistically significant.
Results
According to the obtained results, there was a trend toward more favorable clinical outcomes in terms of needing mechanical ventilation and ICU care, number of ventilator-free days, change in PaO
2
:FiO
2
ratios during the first 5 days after treatment, clinical status score at day 28, length of ICU and hospital stay, and overall 28-day mortality in patients receiving dexamethasone compared to those receiving methylprednisolone or hydrocortisone; however, likely due to the study’s small sample size, the difference between groups reached a significant level only in the case of clinical status score on day 28 (
p
-value = 0.003). There was no significant difference in the incidence of serious adverse events between the study groups.
Conclusion
Based on the results, severe cases of COVID-19 treated with dexamethasone might have a better clinical status at 28-day follow-up compared to methylprednisolone and hydrocortisone at an equivalent dose. Larger multicenter trials are required to confirm our findings.
Introduction: Today, pain is important since it is considered as the fifth vital sign. In patients with decreased consciousness, it is often difficult to detect pain due to the communication barriers. Therefore, this study was conducted to evaluate effect of using Behavioral Pain Scale (BPS) by nurses on diagnosis of Pain and Relief Care in ICU Patients.Methods: This semi-experimental single-group study was conducted with the participation of 68 nurses in the intensive care unit of Hamadan hospitals and selected by census sampling method. The ability to diagnose pain and determine its severity in patients, and pain management methods used by nurses, were evaluated based on the researcher made checklist of evaluation of pain relief before and after the training of behavioral pain monitoring. The collected data were analyzed using SPSS 18. Descriptive statistics were used to determine the frequency, mean, and analytical statistics for comparing ratios and Kolmogorov-Smirnov and Chi-square (P<0.05).
Results:The findings showed that after the intervention, the ability to diagnose pain by nurses has optimally changed. The frequency of use of pain relief drug methods increased from 625 to 1222, and the use of non-pharmacological pain relief also increased significantly (P< 0/001).
Conclusion:The results of this study indicated that the use of BPS scale has been effective in diagnosing and monitoring pain in patients with decreased consciousness, and has led to optimal changes in the use of non-pharmacological pain relief medications as complementary therapies in intensive care units.
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