Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Poisoning

Treatments: Procedure: Hemodialysis; Procedure: HP-HD; Procedure: Hemoperfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03314909

HeSAPP

Details and patient eligibility

About

HeSAPP is a single-center, non-blinded, parallel-group randomized controlled trial studying the hemopurification strategy for acute paraquat(PQ) poisoned patients. The intervention to be investigated include hemodialysis (HD), hemoperfusion (HP), combined hemoperfusion-hemodialysis concurrent therapy (HP-HD) and conservative therapy. The object of the present trial is to investigate whether hemopurification therapy can reduce mortality compared with conservative therapy.

Full description

Patients diagnosed with acute paraquat poisoning in the Emergency Room of the First Affiliated Hospital of Zhengzhou University would be stratified according to their urine dithionite test results and randomly assigned to four different groups: HD, HP, HP-HD and control (conservative therapy) group for different treatment. Arterial blood gas test, complete blood count, coagulation function, liver function, pancreatic function, urine dithionite test, renal function and chest radiographs would be closely monitored during treatment. Primary endpoint is 28-day mortality. Secondary endpoints include (1) survival time (from the time of PQ ingestion to the time of death), all-cause mortality at the 3rd, 7th and 60th day; (2) rate of necessary oxygen uptake and rate of mechanical ventilation; (3) in-hospital length of stay and ICU length of stay; (4) APACHE II score and PSS score; (5) rate of general complications, such as respiratory failure, acute kidney injury (AKI), acute liver failure, pancreas function abnormality and Multiple Organ Failure (MOF); (6) rate of intervention related complications, such as catheter placement related complications, thrombocytopenia and deep venous thrombosis; (7) rate of adverse events, which include unexpected death, severe hemorrhage or edema, unplanned extubation, coagulation in the extracorporeal circulation, blockage of cartridge, incorrect pipe connection, etc.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected paraquat ingestion history (intended or accidental), which is confirmed by positive urine dithionite result (light blue, navy blue and dark blue).
• Arriving at the ER within 24 hours after PQ digestion.
• No known current pregnancy or lactation.
• Absence of cardiac arrest after poisoning, and no previous or present history of chronic kidney disease, chronic liver disease, respiratory failure, COPD, asthma, heart failure, pancreatic disease, acute coronary syndrome (ACS) or stoke.
• No known combined ingestion with other poisons or alcohol.
• No previous blood purification treatment prior to admission.
• No known participation in other medical trials.
• Agreement on informed consent.

Exclusion criteria

• Patients who are unable to comply with the procedures of the present trial, including those who change therapy or withdraw treatment.
• Patients who develop severe allergic response to HP materials.
• Patients who do not receive intervention within 4 hours after admission in reality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 4 patient groups

Hemodialysis (HD)

Experimental group

Description:

Patients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy.

Treatment:

Procedure: Hemodialysis

Hemoperfusion (HP)

Experimental group

Description:

Patients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy.

Treatment:

Procedure: Hemoperfusion

HP-HD

Experimental group

Description:

Patients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy.

Treatment:

Procedure: HP-HD

Conservative

No Intervention group

Description:

Patients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification.