Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This study is designed as a non-blinded trial because of the apparently different equipment of the interventions

Study Groups

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Hemodialysis (HD)

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

Group Type EXPERIMENTAL

Hemodialysis

Intervention Type PROCEDURE

Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.

Hemoperfusion (HP)

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

Group Type EXPERIMENTAL

Hemoperfusion

Intervention Type PROCEDURE

Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.

HP-HD

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

Group Type EXPERIMENTAL

HP-HD

Intervention Type PROCEDURE

Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine and then a hemodialysis machine for one course.

Conservative

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hemodialysis

Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.

Intervention Type PROCEDURE

Hemoperfusion

Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.

Intervention Type PROCEDURE

HP-HD

Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine and then a hemodialysis machine for one course.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No