Evaluation of Pain Scales and Outcome in Critically Ill Patients of a Greek ICU.

The purpose of the study was to evaluate painful procedures in ICU patients and to investigate their effect as well as the role of analgesia in the outcome. We measured pain level and vital signs before, during and after potentially painful procedures by using the Behavioral Pain Scale (BPS) and the Critical Care Pain Observation Tool (CPOT). We analyzed the correlation of these measurements and of analgesia with the outcome. Twenty-eight patients were subjected to 160 stimuli. There were statistically significant differences in pain scores and most vital signs between the different timepoints (before-during, during-after). Most of them were significantly correlated with each other. Physiotherapy proved to be the most painful procedure. Regarding the outcome, the administration of extra analgesia predicted less days of mechanical ventilation (p = 0.015) and of ICU stay (p = 0.016). The higher change in BPS was correlated with more days of mechanical ventilation [B (95% CI) = 3.640 (1.001-6.280), p = 0.007] and of ICU stay [B (95% CI) = 3.645 (1.035-6.254), p = 0.006]. The higher change in CPOT and the nonuse of extra analgesia were related to increased mortality [OR (95% CI) = 1.492 (1.107-2.011), p = 0.009 and OR (95% CI) = 2.626 (1.013-6.806), p = 0.047]. Increased pain in ICU patients was successfully assessed by the BPS and CPOT and correlated to worse outcomes, which the administration of extra analgesia might improve.

Effect of intravenous clarithromycin in patients with sepsis, respiratory and multiple organ dysfunction syndrome: a randomized clinical trial.

BACKGROUND: Clarithromycin may act as immune-regulating treatment in sepsis and acute respiratory dysfunction syndrome. However, clinical evidence remains inconclusive. We aimed to evaluate whether clarithromycin improves 28-day mortality among patients with sepsis, respiratory and multiple organ dysfunction syndrome. METHODS: We conducted a multicenter, randomized, clinical trial in patients with sepsis. Participants with ratio of partial oxygen pressure to fraction of inspired oxygen less than 200 and more than 3 SOFA points from systems other than the respiratory function were enrolled between December 2017 and September 2019. Patients were randomized to receive 1 gr of clarithromycin or placebo intravenously once daily for 4 consecutive days. The primary endpoint was 28-day all-cause mortality. Secondary outcomes were 90-day mortality; sepsis response (defined as at least 25% decrease in SOFA score by day 7); sepsis recurrence; and differences in peripheral blood cell populations and leukocyte transcriptomics. RESULTS: Fifty-five patients were allocated to each arm. By day 28, 27 (49.1%) patients in the clarithromycin and 25 (45.5%) in the placebo group died (risk difference 3.6% [95% confidence interval (CI) - 15.7 to 22.7]; P = 0.703, adjusted OR 1.03 [95%CI 0.35-3.06]; P = 0.959). There were no statistical differences in 90-day mortality and sepsis response. Clarithromycin was associated with lower incidence of sepsis recurrence (OR 0.21 [95%CI 0.06-0.68]; P = 0.012); significant increase in monocyte HLA-DR expression; expansion of non-classical monocytes; and upregulation of genes involved in cholesterol homeostasis. Serious and non-serious adverse events were equally distributed. CONCLUSIONS: Clarithromycin did not reduce mortality among patients with sepsis with respiratory and multiple organ dysfunction. Clarithromycin was associated with lower sepsis recurrence, possibly through a mechanism of immune restoration. Clinical trial registration clinicaltrials.gov identifier NCT03345992 registered 17 November 2017; EudraCT 2017-001056-55.