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
  Purpose

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.


Condition Intervention
Poisoning by Paraquat With Undetermined Intent
Procedure: CVVH
Procedure: Standardized therapy regimens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning

Resource links provided by NLM:


Further study details as provided by Shanghai 10th People's Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: Standardized therapy regimens
The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning.
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

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 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.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, who were younger than 10 years or older than 70 years, or who had been included in any previous control trials were excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709604

Contacts
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

Locations
China, Shanghai
The division of nephrology, Shanghai 10th people's hosptial Recruiting
Shanghai, Shanghai, China, 200072
Contact: Ai Peng, Ph.D., M.D.    086-21-66302524    pengai@hotmail.com   
Principal Investigator: Ai Peng, Ph.D., M.D.         
The division of nephrolgoy, Shanghai 10th people's hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Ai Peng, Ph.D., M.D.    086-21-66302524    Pengai@hotmail.com   
Sponsors and Collaborators
Ai Peng
Investigators
Principal Investigator: Ai Peng, Ph.D., M.D. Shanghai 10th People's Hospital
  More Information

No publications provided

Responsible Party: Ai Peng, Director of the department of Nephrology, Shanghai 10th poeple's hospital, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01709604     History of Changes
Other Study ID Numbers: 20120830, 8117192
Study First Received: October 11, 2012
Last Updated: October 16, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Shanghai 10th People's Hospital:
acute paraquat poisoning
hemoperfusion
continuous blood purification

Additional relevant MeSH terms:
Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 16, 2014