Poisoning by Paraquat With Undetermined IntentPQNCT01709604
Role of CVVH in Patients With Acute Paraquat Poisoning
An observational study of Poisoning by Paraquat With Undetermined Intent, run by Ai Peng at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Poisoning by Paraquat With Undetermined Intent
- What is being tested?
- CVVH and Standardized therapy regimens
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 110 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In-patients with acute paraquat poisoning
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The division of nephrolgoy, Shanghai 10th people's hospital
Shanghai, Shanghai Municipality, 200072
The division of nephrology, Shanghai 10th people's hosptial
Shanghai, Shanghai Municipality, 200072
About this study
Official title: 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, an prospective clinical study would be carried out.
Read the 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.
- Being tested
- CVVH, Standardized therapy regimens
- Keywords
- acute paraquat poisoning, hemoperfusion, continuous blood purification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVHProcedure or surgery
Also called continuous renal replacement treatment(CRRT), continuous blood purification(CBP)
Ultrafiltration at 35ml/h/Kg
Standardized therapy regimensProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CVVH | |
| Standardized therapy regimens | The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning. Receives: Procedure: CVVH; Procedure: Standardized therapy regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-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).
Measured: at 6 months after paraquat poisoning
Secondary outcomes (1)
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.
Measured: at 2 weeks after paraquat poisoning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poisoning by Paraquat With Undetermined IntentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ai Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Ai Peng, Ph.D., M.D., Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709604
- Sponsor's protocol ID
- 20120830
- Other IDs
- 8117192
- Acronym
- PQ
- Status last verified
- Jun 2016
- First submitted
- 11 Oct 2012
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Continuous Venovenous Hemofiltration in Patients With Severe Acute Paraquat Poisoning
- ClinicalTrials.gov ID
- NCT01709604
- Acronym / sponsor ID
- PQ / 20120830
- Keywords
- acute paraquat poisoning, hemoperfusion, continuous blood purification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ai PengUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous venovenous hemofiltration | – | Procedure: CVVHContinuous 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. |
| Standardized therapy regimens | – | Procedure: CVVH, Procedure: Standardized therapy regimensThe standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In-patients with acute paraquat poisoning
Key inclusion criteria (5 listed)
- All patients recruited in this study should meet the requirements as follows:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVVHAlso: continuous renal replacement treatment(CRRT), continuous blood purification(CBP)Ultrafiltration at 35ml/h/Kg | Procedure or surgery | Standardized therapy regimens, continuous venovenous hemofiltration |
| Standardized therapy regimensStandardized 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 | Procedure or surgery | Standardized therapy regimens |
Primary outcome
Efficacy
Time frame: at 6 months after paraquat poisoning
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 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).
1 secondary outcome
Safety of CVVH for the treatment of patients
Time frame: at 2 weeks after paraquat poisoning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ai Peng, Ph.D., M.D. principal investigator
Shanghai 10th People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poisoning by Paraquat With Undetermined Intent, run by Ai Peng at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: at 6 months after paraquat poisoning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.