Phase III, Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock.
Specifically:
-
To evaluate the survival to 28 days of mechanical assisted ventilation, days with vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution towards the failure of other organs.
-
To evaluate, waiting for reduction under the influence of the treatment with melatonin, :
-
clinical - analytical parameters of sepsis;
-
levels of cytokines;
-
oxidative and nitrosative stress;
-
acute-phase proteins (APP), specially of the ITIH4;
-
immune response;
-
endocrine response.
METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment with melatonin 30mg/12 hours 28 days; 2) placebo.
Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase activity; d) Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins: PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins; g) cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3. Data will be analyzed following a prospectively define plan and by intention-to-treat (ITT) analysis.
详细描述
This study will be done in the Hospital Clinico Lozano Blesa (Zaragoza, Spain), promoted by the Health Science Aragon Institute and its principal investigator is F. Agustín García Gil (Surgical Service). It will start in April-May 2013 and will finish 12 months later approximately. The study sponsor is I+CS (Aragon Institute of Health Sciences).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (males and females) over 18 years who meet the diagnostic criteria for severe sepsis or septic shock secondary to community-acquired pneumonia or hospital and or intra-abdominal infection
排除标准
- •Patient with more than 24 hours from the first documentation of organ dysfunction
研究组 & 干预措施
Melatonin
Oral 30mg/12hours melatonin 28 days
干预措施: Melatonin (Drug)
结局指标
主要结局
Mortality
时间窗: 1 month
Mortality at 28 days of study entry.
Clinical evolution parameters
时间窗: 1 month
Days of mechanical ventilation. Days with vasoactive drugs. Days with hemodialysis or hemofiltration. Superinfection of organs other than the initial cause of the sepsis. Progression to other organs fail after starting the treatment.
次要结局
- Clinical evolution(1 month)
- Oxidative-nitrosative parameters(1 month)
- Inflammatory parameters(1 month)
- Acute phase proteins(1 month)
- Immune parameters(1 month)
- Endocrine parameters(1 month)