<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709604</url>
  </required_header>
  <id_info>
    <org_study_id>20120830</org_study_id>
    <secondary_id>8117192</secondary_id>
    <nct_id>NCT01709604</nct_id>
  </id_info>
  <brief_title>Role of CVVH in Patients With Acute Paraquat Poisoning</brief_title>
  <acronym>PQ</acronym>
  <official_title>The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ai Peng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 10th People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with&#xD;
      respiratory failure. Accumulating evidence suggested that continuous venovenous&#xD;
      hemofiltration (CVVH) had a beneficial role in the treatment of multiple organ dysfunction.&#xD;
      The investigators hypothesized that CVVH might restore multiple organ function and reduce the&#xD;
      high mortality rate of paraquat poisoning. To confirm it, an prospective clinical study would&#xD;
      be carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Paraquat (1,1 '-dimethyl-4,4'-bipyridylium dichloride) is widely used as a herbicide.&#xD;
      Accidental or intentional ingestion of paraquat is common in many developing countries such&#xD;
      as China, Sri Lanka and Korea because of easy access. The high mortality rate of paraquat is&#xD;
      due to its high toxicity and the lack of effective treatments. Thus, the paraquat poisoning&#xD;
      becomes one of major medical problem in the developing countries.&#xD;
&#xD;
      Paraquat poisoning is also one of major causes of death among young patients with acute&#xD;
      poisoning in China. It is characterized by multiple organ failure and pulmonary fibrosis with&#xD;
      respiratory failure. A growing body of evidence suggested that continuous venovenous&#xD;
      hemofiltration (CVVH) had a great beneficial role in the treatment of multiple organ&#xD;
      dysfunctions. We hypothesized that CVVH might reduce the high mortality rate of paraquat&#xD;
      poisoning via restoring the multiorgan function, such as acute hepatic lesion, acute kidney&#xD;
      injury, acute lung injury and acute pancreatic injury. We expect to enroll 100 patients from&#xD;
      our hospital within 1 week after oral intake of paraquat. All patients were divided into&#xD;
      Group 1 and Group 2. Group 1 were treated with a standardized therapeutic regimen including&#xD;
      stomach lavage, emergency haemoperfusion and drugs. Group 2 were accepted with standardized&#xD;
      treatment plus CVVH. The aim of this prospective clinical study was to evaluate the safety&#xD;
      and efficacy of CVVH for the treatment of patients with paraquat poisoning. The survival&#xD;
      rate, clinical manifestations and clinical parameters between these two groups were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy</measure>
    <time_frame>at 6 months after paraquat poisoning</time_frame>
    <description>CVVH treatment efficacy was assessed by the following measurements:&#xD;
Mortality rate: compared the difference between standardized therapy and CVVH treatment.&#xD;
Number of organs involved in paraquat poisoning such as lung,kidney,liver and heart.&#xD;
Degree of organ injuries&#xD;
CT scan of lung&#xD;
Biomarkers:&#xD;
1)Oxidative stress: blood superoxide dismutase(SOD),malondialdehyde (MDA), superoxide dismutase (SOD), and catalase (CAT).&#xD;
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.&#xD;
4)Heart damage markers: cTnT，MYO，creatine kinase-MB(CK-MB) and brain natriuretic peptide(BNP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of CVVH for the treatment of patients</measure>
    <time_frame>at 2 weeks after paraquat poisoning</time_frame>
    <description>Safety and tolerability were assessed by the followings.&#xD;
Changes from baseline in systolic blood pressure and mean artery pressure during CVVH treatment procedure.&#xD;
Number of participants with adverse events such as bleeding, respiratory failure,hypotension,shock,thrombosis,pulmonary embolism and death.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Poisoning by Paraquat With Undetermined Intent</condition>
  <arm_group>
    <arm_group_label>continuous venovenous hemofiltration</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standardized therapy regimens</arm_group_label>
    <description>The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CVVH</intervention_name>
    <description>Ultrafiltration at 35ml/h/Kg</description>
    <arm_group_label>Standardized therapy regimens</arm_group_label>
    <arm_group_label>continuous venovenous hemofiltration</arm_group_label>
    <other_name>continuous renal replacement treatment(CRRT)</other_name>
    <other_name>continuous blood purification(CBP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standardized therapy regimens</intervention_name>
    <description>Standardized therapy regimens included the followings:&#xD;
Remove all contaminated clothing&#xD;
Gastric lavage&#xD;
Receive activated charcoal as quickly as possible&#xD;
Hemoperfusion with activated charcoal(160g)&#xD;
Immunosuppression with methylprednisolone&#xD;
Antioxidants (glutathione,1.2 gram iv twice a day)&#xD;
Supportive care</description>
    <arm_group_label>Standardized therapy regimens</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, Plasma, Urine,Dialysate&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In-patients with acute paraquat poisoning&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients recruited in this study should meet the requirements as follows:&#xD;
&#xD;
               1. history of exposure to Paraquat&#xD;
&#xD;
               2. concentration in urine or plasma from all patients who arrived at our hospital&#xD;
                  within 1 week of paraquat ingestion was more than 0.1 mg/L.&#xD;
&#xD;
               3. Patients with a light blue, navy blue or dark blue color in urine dithionite&#xD;
                  tests within 1 week of PQ ingestion, were classified as having PQ intoxication&#xD;
                  and were included in this study.&#xD;
&#xD;
               4. patients with acute organ dysfunction such as acute kidney injury, hepatic injury&#xD;
                  or pancreatic injury.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
        Patients who had colorless urine PQ tests, who arrived at any hospital more than 24 h after&#xD;
        intoxication, who had not orally ingested PQ or any other drug poisonings, who were younger&#xD;
        than 14 years or older than 70 years, or who had been included in any previous control&#xD;
        trials were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ai Peng, Ph.D., M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai 10th People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The division of nephrolgoy, Shanghai 10th people's hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The division of nephrology, Shanghai 10th people's hosptial</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>June 11, 2016</last_update_submitted>
  <last_update_submitted_qc>June 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Ai Peng</investigator_full_name>
    <investigator_title>Director of the department of Nephrology, Shanghai 10th poeple's hospital</investigator_title>
  </responsible_party>
  <keyword>acute paraquat poisoning</keyword>
  <keyword>hemoperfusion</keyword>
  <keyword>continuous blood purification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709604
org study id: 20120830
secondary id: 8117192
nct id: NCT01709604
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Efficacy
time frame: at 6 months after paraquat poisoning
description: 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-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).
measure: Safety of CVVH for the treatment of patients
time frame: at 2 weeks after paraquat poisoning
description: 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.
arm group label: continuous venovenous hemofiltration
description: 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.
arm group label: Standardized therapy regimens
description: The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning.
intervention type: Procedure
intervention name: CVVH
description: Ultrafiltration at 35ml/h/Kg
arm group label: Standardized therapy regimens
arm group label: continuous venovenous hemofiltration
other name: continuous renal replacement treatment(CRRT)
other name: continuous blood purification(CBP)
intervention type: Procedure
intervention name: Standardized therapy regimens
description: Standardized therapy regimens included the followings:
Remove all contaminated clothing
Gastric lavage
Receive activated charcoal as quickly as possible
Hemoperfusion with activated charcoal(160g)
Immunosuppression with methylprednisolone
Antioxidants (glutathione,1.2 gram iv twice a day)
Supportive care
arm group label: Standardized therapy regimens
Serum, Plasma, Urine,Dialysate
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ai Peng, Ph.D., M.D.
role: Principal Investigator
affiliation: Shanghai 10th People's Hospital
facility: 
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Ai Peng
investigator title: Director of the department of Nephrology, Shanghai 10th poeple's hospital
mesh term: Poisoning
sharing ipd: No