- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709604
Role of CVVH in Patients With Acute Paraquat Poisoning (PQ)
The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200072
- The division of nephrolgoy, Shanghai 10th people's hospital
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Shanghai, Shanghai, China, 200072
- The division of nephrology, Shanghai 10th people's hosptial
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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continuous venovenous hemofiltration
Continuous venovenous hemofiltration(CVVH):blood access was achieved by placing a double lumen catheter in the femoral or internal jugular vein.
Continuous diffusive solute transport is achieved by infusing a dialysis fluid that runs counter-current to blood at an ultrafiltration rate of 35 ml/h/Kg.
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Ultrafiltration at 35ml/h/Kg
Other Names:
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Standardized therapy regimens
The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning.
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Ultrafiltration at 35ml/h/Kg
Other Names:
Standardized therapy regimens included the followings:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: at 6 months after paraquat poisoning
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CVVH treatment efficacy was assessed by the following measurements:
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). |
at 6 months after paraquat poisoning
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety of CVVH for the treatment of patients
Time Frame: at 2 weeks after paraquat poisoning
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Safety and tolerability were assessed by the followings.
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at 2 weeks after paraquat poisoning
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ai Peng, Ph.D., M.D., Shanghai 10th People's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120830
- 8117192 (Other Grant/Funding Number: NSFC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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