Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .
研究概览
简要总结
Inflammatory markers are found to be an important contributor in sepsis. We evaluate the effect of colchicine on inflammatory processes and its possible protective effect against oxidative stress and organ dysfunction in adult patients suffering from sepsis.
详细描述
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, impacting millions of people around the world each year and killing between one in three and one in six of those it affects. Early identification and appropriate management in the initial hours after the development of sepsis improve outcomes .
Large quantities of proinflammatory cytokines released in patients with sepsis may spill into the bloodstream, contributing to the progression of a local infection to sepsis. These include tumor necrosis factor alpha (TNF-α), interleukin-1 (IL-1) and, interleukin-6 (IL-6), all of them can cause fever, hypotension, leukocytosis, induction of other proinflammatory cytokines, and the simultaneous activation of coagulation and fibrinolysis.
Taken together of all the aspects of the pathogenesis of sepsis, treatment modalities with anti-inflammatory effects could be considered for the successful treatment of sepsis. The available treatment strategies for management of sepsis include the use of fluid resuscitation and Empiric antibiotic therapy .
However, the limited success of antimicrobial in reducing the high mortality associated with sepsis and septic shock, increasing antibiotic resistance and medicine-resistant hemodynamic changes and our improved understandings of the pathogenesis of sepsis have resulted in further research on new treatment modalities in addition to classical treatments .
In particular, the identification of endotoxin-induced TNF-α and IL-1 production during sepsis as a major mediator of host damage, which culminates in potentially irreversible multi-organ dysfunction and shock, has led to the experimental use of a variety of interventions .
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
- Double (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 (Control group)
干预措施: conventional sepsis therapy alone (Drug)
Group 2 (Colchicine group)
干预措施: colchicine 500 mcg oral twice daily plus conventional sepsis therapy. (Drug)
结局指标
主要结局
change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .
时间窗: 10 Months
decrease in (TNF-α) level means improvement from sepsis and better outcome
change in the measured biological marker Serum Malondialdehyde (MDA).
时间窗: 10 Months
decrease in Serum Malondialdehyde (MDA) level means improvement from sepsis and better outcome.
次要结局
- change in Sequential Organ Failure Assessment (SOFA) score(10 Months)
研究者
Randa Hamza Ismail Elmohr
Dr
Tanta University
