Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Death rate
研究概览
简要总结
This is a prospective, multicentre clinical study to determine the value of the Extracorporeal Membrane Oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the prognosis of different types or doses of poison/drug poisoning. These conclusions may guide us on how to correctly perform Extracorporeal Membrane Oxygenation, including whether or when should this treatment enabled, the mode of Extracorporeal Membrane Oxygenation, whether to combine blood purification, treatment schedule and disembarkation time.
详细描述
This study will be conducted in the Affiliated Hospital of Nantong University, the Sixth People's Hospital of Nantong University, the Branch of Affiliated Hospital of Nantong University, the People's Hospital of Qidong City, the People's Hospital of Rudong County, the People's Hospital of Rugao City, and the People's Hospital of Hai 'an City. It is expected that 60 patients with poisoning will be included, and the blood and urine samples of 60 patients will be collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record will be established.
The purpose of this prospective multicenter observational clinical study was to 1) investigate the value of Extracorporeal Membrane Oxygenation in the treatment of fatal poisoning; 2) To investigate the changes of patients' organ functions (heart, lung, liver, kidney, brain) during the Extracorporeal Membrane Oxygenation operation and the influence on the removal of toxins. In order to obtain a more powerful clinical basis to guide the rational use of the Extracorporeal Membrane Oxygenation technology in patients with fatal poisoning.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.
- •Denying other available methods.
- •Indications for the use of the Extracorporeal membrane oxygenation exist.
排除标准
- •Severely impaired state of consciousness prior to cardiac arrest;
- •Multiple organ dysfunction;
- •Uncontrolled traumatic bleeding, massive gastrointestinal bleeding, and active intracranial hemorrhage;
- •Left ventricular thrombosis; Severe aortic insufficiency.
结局指标
主要结局
Death rate
时间窗: through study completion, assessed up to 3 year
Death rate is used to assess the treatment capacity of Extracorporeal membrane oxygenation.
Complication
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Complication is used to assess the side effects of Extracorporeal membrane oxygenation.
Partial pressure of oxygen
时间窗: immediately after performing extracorporeal membrane oxygenation
PO₂ is used to indicate the state of internal respiration.
Oxygen saturation
时间窗: immediately after performing extracorporeal membrane oxygenation
SO₂ is used to indicate the state of internal respiration.
次要结局
未报告次要终点