The Efficacy of Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults: Study Protocol for a Randomized Controlled Trial (HeSAPP)
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
HeSAPP is a single-center, non-blinded, parallel-group randomized controlled trial studying the hemopurification strategy for acute paraquat(PQ) poisoned patients. The intervention to be investigated include hemodialysis (HD), hemoperfusion (HP), combined hemoperfusion-hemodialysis concurrent therapy (HP-HD) and conservative therapy. The object of the present trial is to investigate whether hemopurification therapy can reduce mortality compared with conservative therapy.
详细描述
Patients diagnosed with acute paraquat poisoning in the Emergency Room of the First Affiliated Hospital of Zhengzhou University would be stratified according to their urine dithionite test results and randomly assigned to four different groups: HD, HP, HP-HD and control (conservative therapy) group for different treatment. Arterial blood gas test, complete blood count, coagulation function, liver function, pancreatic function, urine dithionite test, renal function and chest radiographs would be closely monitored during treatment. Primary endpoint is 28-day mortality. Secondary endpoints include (1) survival time (from the time of PQ ingestion to the time of death), all-cause mortality at the 3rd, 7th and 60th day; (2) rate of necessary oxygen uptake and rate of mechanical ventilation; (3) in-hospital length of stay and ICU length of stay; (4) APACHE II score and PSS score; (5) rate of general complications, such as respiratory failure, acute kidney injury (AKI), acute liver failure, pancreas function abnormality and Multiple Organ Failure (MOF); (6) rate of intervention related complications, such as catheter placement related complications, thrombocytopenia and deep venous thrombosis; (7) rate of adverse events, which include unexpected death, severe hemorrhage or edema, unplanned extubation, coagulation in the extracorporeal circulation, blockage of cartridge, incorrect pipe connection, etc.
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
- None
盲法说明
This study is designed as a non-blinded trial because of the apparently different equipment of the interventions
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected paraquat ingestion history (intended or accidental), which is confirmed by positive urine dithionite result (light blue, navy blue and dark blue).
- •Arriving at the ER within 24 hours after PQ digestion.
- •No known current pregnancy or lactation.
- •Absence of cardiac arrest after poisoning, and no previous or present history of chronic kidney disease, chronic liver disease, respiratory failure, COPD, asthma, heart failure, pancreatic disease, acute coronary syndrome (ACS) or stoke.
- •No known combined ingestion with other poisons or alcohol.
- •No previous blood purification treatment prior to admission.
- •No known participation in other medical trials.
- •Agreement on informed consent.
排除标准
- •Patients who are unable to comply with the procedures of the present trial, including those who change therapy or withdraw treatment.
- •Patients who develop severe allergic response to HP materials.
- •Patients who do not receive intervention within 4 hours after admission in reality.
研究组 & 干预措施
Hemodialysis (HD)
Patients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy.
干预措施: Hemodialysis (Procedure)
Hemoperfusion (HP)
Patients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy.
干预措施: Hemoperfusion (Procedure)
HP-HD
Patients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy.
干预措施: HP-HD (Procedure)
Conservative
Patients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification.
结局指标
主要结局
28-day all-cause mortality
时间窗: From the day of intoxication to the 28th day afterwards.
Mortality=Dead patients/All patients in that group
次要结局
- 60-day all-cause mortality(From the day of intoxication to the 60th day afterwards.)
- ICU length of stay(From the day of intoxication to death or the 60th day.)
- Survival time(From the day of intoxication to death or the 60th day.)
- 7-day all-cause mortality(From the day of intoxication to the 7th day afterwards.)
- Rate of mechanical ventilation(From the day of intoxication to death or the 60th day.)
- 3-day all-cause mortality(From the day of intoxication to the 3rd day afterwards.)
- Rate of catheter related complications(From the day of intoxication to death or the 60th day.)
- Rate of oxygen uptake(From the day of intoxication to death or the 60th day.)
- In-hospital length of stay(From the day of admission to discharge or up to 60 days after admission.)
- Rate of multiple organ failure(From the day of intoxication to death or the 60th day.)
研究者
Yi Li, MD
Chief physician of Emergency Department, professor
Peking Union Medical College Hospital