IntroductionAbout 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).Methods and analysisPhase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm).Ethics and disseminationThe clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.Trial registration numberNCT04357860.
Results: Patients were characterized by relatively low MBPS indices. There were no significant differences in all three MBPS indices between 1 and 2 recording (rec.). All three indices were characterized by good reproducibility indices RC, %M and %MV (Table).
Conclusions:In never-treated hypertensive patients all three MBPS indices are characterized by good reproducibility.Objective: The aim of study was to definite if the emotional intelligence (EI) and psychological status (PS) of patients with arterial hypertension (AH) can moderate the difference between clinical and ambulatory blood pressure (CABP) level.
Design and Methods:We assessed 214 ambulatory blood pressure monitoring (ABPM) data of AH patients. ABPM monitor (SpaceLabs 90207) was applied after the washout period. The CABP discrepancy was assessed as the difference between clinical BP and mean daytime BP measurement. After ABPM session patients completed the PS and EI questionnaire: "Minnesota Multiphase Personality Inventory" (MMPI short form) and "EmIn Questionnaire" (Lyusin D.). We used Spearman Partial Coefficient for correlation analysis adjusted for age, sex and duration of AH.
Results:The mean daytime BP was (M ± SD): systolic (SBP) -141.1 ± 14.2; diastolic (DBP) -89.1 ± 9.5 mm Hg. We found correlations (r) between PS and CABP difference: 1) positive -between psychological and emotional impulsivity (3, 4 MMPI scales) (r = 0.190 and 0.277) combined with social conform, self-control (7, K MMPI scales)(r = 0.263 and 0.178); 2) negative -with psychological disadaptation, leadership traits, aggression level, (F, 6 MMPI scales) (r = -0.204 and -0.177). Also, we found relationship between EI and CABP discrepancy: emotion self-awareness and management of others' emotions (ESA, MOE scales of EmIn) (r = 0.33 and 0.38).
Conclusion:The degree of CABP difference is associated with high social conform and self -control, emotion self-awareness combined with psychological and emotional impulsivity, wish for management of others' emotions. CABP difference is less probable in patients with high aggression level, psychological disadaptation, leadership traits.
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