Dose assessment of melatonin in sepsis trial (DAMSEL 2) - Melatonin in sepsis

niversity of Aberdeen0 个研究点目标入组 50 人开始时间: 2014年10月24日最近更新: 2020年3月18日

适应症

试验速览

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•Adult patients (16 y or above) on the ICU at Aberdeen Royal Infirmary with sepsis due to community acquired pneumonia who are within 24h of fulfilling the criteria for sepsis with clinical suspicion of pneumonia and the presence of chest X-ray changes consistent with pneumonia will be recruited. The criteria for sepsis are:
•clinical suspicion or evidence of acute infection
•systemic inflammatory response syndrome, defined by two or more of the following:
•1.Core temperature <36 or >38°C;
•2.tachycardia: heart rate > 90 beats/min;
•3.tachypnoea: respiratory rate > 20 breaths/min or ventilated;
•4.leucocyte count >12 x 10^9/L or <4 x 10^9/L.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•Exclusions:
•<16 years old,
•have a life expectancy <24h,
•have metastatic cancer or immunosuppression,
•are receiving steroids (>20mg/d prednisolone or equivalent, used regularly for >2 weeks prior to ICU admission) or are
•women of child bearing potential without a negative pregnancy test or a history of surgical sterilization.
•patients receiving fluvoxamine or nifedipine,
•those with overt hepatic failure
•those who are unable to understand or comply with the requirements of the trial

发起方

niversity of Aberdeen