Role of CVVH in Patients With Acute Paraquat Poisoning (PQ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Shanghai 10th People's Hospital
Sponsor:
Information provided by (Responsible Party):
Ai Peng, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT01709604
First received: October 11, 2012
Last updated: October 16, 2012
Last verified: October 2012

October 11, 2012
October 16, 2012
October 2008
October 2014   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: at 6 months after paraquat poisoning ] [ Designated as safety issue: No ]

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 GFR 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,CK-MB and BNP.

Same as current
Complete list of historical versions of study NCT01709604 on ClinicalTrials.gov Archive Site
Safety of CVVH for the treatment of patients [ Time Frame: at 2 weeks after paraquat poisoning ] [ Designated as safety issue: No ]

Safety and tolerability were assessed by the followings.

  1. Changes from baseline in systolic blood pressure and mean artery pressure during CVVH treatment procedure.
  2. Number of participants with adverse events such as bleeding, respiratory failure,hypotension,shock,thrombosis,pulmonary embolism and death.
Same as current
Not Provided
Not Provided
 
Role of CVVH in Patients With Acute Paraquat Poisoning
The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning

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, a prospective clinical study would be carried out.

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 randomly divided into Group 1 and Group 2. Group 1 (n=50) were treated with a standardized therapeutic regimen including stomach lavage, emergency haemoperfusion and drugs. Group 2 (n=50) 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Poisoning by Paraquat With Undetermined Intent
  • Procedure: CVVH
    Ultrafiltration at 35ml/h/Kg
    Other Names:
    • continuous renal replacement treatment(CRRT)
    • continuous blood purification(CBP)
  • Procedure: Standardized therapy regimens

    Standardized therapy regimens included the followings:

    1. Remove all contaminated clothing
    2. Gastric lavage
    3. Receive activated charcoal as quickly as possible
    4. Hemoperfusion with activated charcoal(160g)
    5. Immunosuppression with methylprednisolone
    6. Antioxidants (glutathione,1.2 gram iv twice a day)
    7. Supportive care
  • Experimental: 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.
    Interventions:
    • Procedure: CVVH
    • Procedure: Standardized therapy regimens
  • Active Comparator: Standardized therapy regimens
    The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning.
    Intervention: Procedure: Standardized therapy regimens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2015
October 2014   (final data collection date for primary outcome measure)

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, who were younger than 10 years or older than 70 years, or who had been included in any previous control trials were excluded.

Both
10 Years to 70 Years
No
Contact: Ai Peng, Ph.D. M.D. 086-21-66302524 pengai@hotmail.com
Contact: Changbin Li, M.D. 086-21-66301050 08doctorlee@tongji.edu.cn
China
 
NCT01709604
20120830, 8117192
Yes
Ai Peng, Shanghai 10th People's Hospital
Ai Peng
Not Provided
Principal Investigator: Ai Peng, Ph.D., M.D. Shanghai 10th People's Hospital
Shanghai 10th People's Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP