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临床试验/NCT01709604
NCT01709604已完成不适用

The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning

Ai Peng2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Efficacy

研究概览

简要总结

Paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with respiratory failure. Accumulating evidence suggested that continuous venovenous hemofiltration (CVVH) had a beneficial role in the treatment of multiple organ dysfunction. The investigators hypothesized that CVVH might restore multiple organ function and reduce the high mortality rate of paraquat poisoning. To confirm it, an prospective clinical study would be carried out.

详细描述

Paraquat (1,1 '-dimethyl-4,4'-bipyridylium dichloride) is widely used as a herbicide. Accidental or intentional ingestion of paraquat is common in many developing countries such as China, Sri Lanka and Korea because of easy access. The high mortality rate of paraquat is due to its high toxicity and the lack of effective treatments. Thus, the paraquat poisoning becomes one of major medical problem in the developing countries.

Paraquat poisoning is also one of major causes of death among young patients with acute poisoning in China. It is characterized by multiple organ failure and pulmonary fibrosis with respiratory failure. A growing body of evidence suggested that continuous venovenous hemofiltration (CVVH) had a great beneficial role in the treatment of multiple organ dysfunctions. We hypothesized that CVVH might reduce the high mortality rate of paraquat poisoning via restoring the multiorgan function, such as acute hepatic lesion, acute kidney injury, acute lung injury and acute pancreatic injury. We expect to enroll 100 patients from our hospital within 1 week after oral intake of paraquat. All patients were divided into Group 1 and Group 2. Group 1 were treated with a standardized therapeutic regimen including stomach lavage, emergency haemoperfusion and drugs. Group 2 were accepted with standardized treatment plus CVVH. The aim of this prospective clinical study was to evaluate the safety and efficacy of CVVH for the treatment of patients with paraquat poisoning. The survival rate, clinical manifestations and clinical parameters between these two groups were compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients recruited in this study should meet the requirements as follows:
  • history of exposure to Paraquat
  • concentration in urine or plasma from all patients who arrived at our hospital within 1 week of paraquat ingestion was more than 0.1 mg/L.
  • Patients with a light blue, navy blue or dark blue color in urine dithionite tests within 1 week of PQ ingestion, were classified as having PQ intoxication and were included in this study.
  • patients with acute organ dysfunction such as acute kidney injury, hepatic injury or pancreatic injury.

排除标准

  • Patients who had colorless urine PQ tests, who arrived at any hospital more than 24 h after intoxication, who had not orally ingested PQ or any other drug poisonings, who were younger than 14 years or older than 70 years, or who had been included in any previous control trials were excluded.

结局指标

主要结局

Efficacy

时间窗: at 6 months after paraquat poisoning

CVVH treatment efficacy was assessed by the following measurements: 1. Mortality rate: compared the difference between standardized therapy and CVVH treatment. 2. Number of organs involved in paraquat poisoning such as lung,kidney,liver and heart. 3. Degree of organ injuries 4. CT scan of lung 5. Biomarkers: 1)Oxidative stress: blood superoxide dismutase(SOD),malondialdehyde (MDA), superoxide dismutase (SOD), and catalase (CAT). 2)Proinflammatory factors: interleukins(IL-2,IL-6,IL-8 and IL-10) 3)Kidney function:serum cystatin C and estimated glomerular filtration rate (eGFR) and N-acetyl-β-(D)-glucosaminidase activity (NAG),kidney injury molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin(NAGL) and urinary retinol-binding protein(RBP),etc. 4)Heart damage markers: cTnT,MYO,creatine kinase-MB(CK-MB) and brain natriuretic peptide(BNP).

次要结局

  • Safety of CVVH for the treatment of patients(at 2 weeks after paraquat poisoning)

研究者

发起方
Ai Peng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ai Peng

Director of the department of Nephrology, Shanghai 10th poeple's hospital

Shanghai 10th People's Hospital

研究点 (2)

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