Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Incidence rate of Organ failure
研究概览
简要总结
Cytokines such as such as TNF-a, IL-1, IL-6 correlate with the severity of pancreatitis.Neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. The investigators aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous system, thus relieve inflammation response.
详细描述
Infected pancreatic necrosis (IPN) and multiple organ dysfunction syndrome (MODS) are major complications of acute pancreatitis which determine disease severity and outcome.It is concluded that systemic inflammation in SAP characterized by the endocrine release of different cytokines, such as TNF-a, IL-1, IL-6 and many others. These cytokines correlate with the severity of pancreatitis.
Neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. Dexmedetomidine Hydrochloride is a high selected a-2 adrenoreceptor agonists.Some studies have shown that Dexmedetomidine Hydrochloride could improve the outcome of sepsis patients and decrease the development of organ failure.
The investigators aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous system,thus relieve inflammation response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with severe acute pancreatitis within 48h
- •APACHE II≥8
- •Patients or the family agreed to receive the treatment, and signed the informed consents
排除标准
- •Patients were allergy to the drug
- •Patients were diagnosed with Arrhythmia
- •Patients with artificial permanent pacemaker implantation
研究组 & 干预措施
Group A
Dexmedetomidine Hydrochloride 4ug/ml；0.05ml/kg.h infusion for 24hours
干预措施: Infusion (Drug)
Group B
Normal Saline 0.05ml/kg.h infusion for 24hours
干预措施: Infusion (Drug)
结局指标
主要结局
Incidence rate of Organ failure
时间窗: 30 days after Incidence of the disease
次要结局
- Infected pancreatic necrosis(30 days after Incidence of the disease)
研究者
Weiqin Li
Dr.
Nanjing University School of Medicine