Role of CVVH in Patients With Acute Paraquat Poisoning

NCT ID: NCT01709604

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-06-30

Brief 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. 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.

Conditions

Poisoning by Paraquat With Undetermined Intent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

CVVH

Intervention Type: PROCEDURE

Ultrafiltration at 35ml/h/Kg

Standardized therapy regimens

The standardized therapy regimens included reduce absorption, accelerate the elimination and prevent the complications in patients with paraquat poisoning.

CVVH

Intervention Type: PROCEDURE

Ultrafiltration at 35ml/h/Kg

Standardized therapy regimens

Intervention Type: PROCEDURE

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

Interventions

CVVH

Ultrafiltration at 35ml/h/Kg

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

continuous renal replacement treatment(CRRT); continuous blood purification(CBP)

Eligibility 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 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ai Peng

OTHER

Sponsor Role: lead

Responsible Party

Ai Peng

Director of the department of Nephrology, Shanghai 10th poeple's hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ai Peng, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

The division of nephrolgoy, Shanghai 10th people's hospital

Shanghai, Shanghai Municipality, China

The division of nephrology, Shanghai 10th people's hosptial

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

8117192

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20120830

Identifier Type: -

Identifier Source: org_study_id