Prospective, randomised, double-blind study to evaluate the efficacy of treatment with melatonin in adult patients with severe sepsis or septic shock.

INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD0 个研究点目标入组 110 人开始时间: 2010年4月16日最近更新: 2013年1月21日

适应症

试验速览

暂无简介。

•a) Patient admitted to the Intensive Care Unit (ICU),
•b) Aged 18 years or over.
•c) Fulfils the diagnostic criteria of severe sepsis or septic shock secondary to extrahospital or intrahospital pneumonia and/or intraabdominal infection.
•d) More than 24 hours has passed after recording the first organ dysfunction.
•e) To be receiving the standard treatments for these conditions according to universally accepted guidelines* (Dellinger RP et al, 2008) and with the antibiotherapy protocol of our ICU.
•f) Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 55

•a) Absence of informed consent.
•b) Patient identified as being very close to death.
•c) Patient expected to die within 28 days from a medical condition that cannot be cured, such as a poorly controlled neoplasm or other terminal illness.
•d) History of organ transplant.
•e) Absence of concomitant intensive treatment.

发起方

INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD