Role of CVVH in Patients With Acute Paraquat Poisoning

NCT01709604 | Completed

• 2 other identifiers: 201208308117192
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Poisoning by Paraquat With Undetermined Intent

Keywords

acute paraquat poisoning; hemoperfusion; continuous blood purification

Outcome Measures

Primary Outcomes (1)

• Efficacy

  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).

  at 6 months after paraquat poisoning

Secondary Outcomes (1)

• Safety of CVVH for the treatment of patients

  at 2 weeks after paraquat poisoning

Study Arms (2)

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

Standardized therapy regimens

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

Procedure: CVVH; Procedure: Standardized therapy regimens

Interventions

CVVH PROCEDURE

Ultrafiltration at 35ml/h/Kg

Also known as: continuous renal replacement treatment(CRRT), continuous blood purification(CBP)

Standardized therapy regimens; continuous venovenous hemofiltration

Standardized therapy regimens 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

Standardized therapy regimens

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In-patients with acute paraquat poisoning

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ai Peng: lead

Study Sites (2)

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

Shanghai, Shanghai Municipality, 200072, China

Location

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

Shanghai, Shanghai Municipality, 200072, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma, Urine,Dialysate

Study Officials

• Ai Peng, Ph.D., M.D.

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the department of Nephrology, Shanghai 10th poeple's hospital

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 18, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)