Dose Assessment of Melatonin in SEpsis triaL: a pilot phase I/II study

niversity of Aberdeen/NHS Grampian (UK)0 个研究点目标入组 10 人开始时间: 2014年8月29日最近更新: 2022年10月10日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36046952/ (added 20/09/2022)

•Patients who are within 24h of fulfilling the criteria for sepsis with clinical suspicion of community acquired 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 plus 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

•1. Anyone <16 years old
•2. Life expectancy <24h
•3. Metastatic cancer or immunosuppression
•4. Taking steroids (>20mg/d prednisolone or equivalent, used regularly for >2 weeks prior to ICU admission)
•5. Premenopausal females without a negative pregnancy test or a history of surgical sterilization.
•6. Patients receiving fluvoxamine or nifedipine
•7. Consent refusal

发起方

niversity of Aberdeen/NHS Grampian (UK)