Clinical trial NCT01709604: Role of CVVH in Patients With Acute Paraquat Poisoning
Official title: The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poisoning by Paraquat With Undetermined Intent
Keywords: acute paraquat poisoning
hemoperfusion
continuous blood purification
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 110
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-patients with acute paraquat poisoning

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients recruited in this study should meet the requirements as follows:

  1. history of exposure to Paraquat
  2. 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.
  3. 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.
  4. patients with acute organ dysfunction such as acute kidney injury, hepatic injury or pancreatic injury.

     Exclusion Criteria:

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.

Primary outcomes:
measure: Efficacy
timeFrame: at 6 months after paraquat poisoning
Secondary outcomes:
measure: Safety of CVVH for the treatment of patients
timeFrame: at 2 weeks after paraquat poisoning
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The division of nephrolgoy, Shanghai 10th people's hospital
state: Shanghai
city: Shanghai
country: China
facility: The division of nephrology, Shanghai 10th people's hosptial
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Ai Peng, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: