Poisoning by Paraquat With Undetermined Intent Clinical Trial
— PQOfficial title:
The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning
| Verified date | June 2016 |
| Source | Shanghai 10th People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: National Natural Science Foundation |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 110 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 70 Years |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | The division of nephrolgoy, Shanghai 10th people's hospital | Shanghai | Shanghai |
| China | The division of nephrology, Shanghai 10th people's hosptial | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ai Peng |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy | CVVH treatment efficacy was assessed by the following measurements: Mortality rate: compared the difference between standardized therapy and CVVH treatment. Number of organs involved in paraquat poisoning such as lung,kidney,liver and heart. Degree of organ injuries CT scan of lung 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-ß-(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 | No |
| Secondary | Safety of CVVH for the treatment of patients | Safety and tolerability were assessed by the followings. Changes from baseline in systolic blood pressure and mean artery pressure during CVVH treatment procedure. Number of participants with adverse events such as bleeding, respiratory failure,hypotension,shock,thrombosis,pulmonary embolism and death. |
at 2 weeks after paraquat poisoning | No |