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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.
Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.
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.
28-day all-cause mortality
Mortality=Dead patients/All patients in that group
Time frame: From the day of intoxication to the 28th day afterwards.
Survival time
Live day count.
Time frame: From the day of intoxication to death or the 60th day.
Rate of multiple organ failure
Patients that develop multiple organ failure/All patients in that group
Time frame: From the day of intoxication to death or the 60th day.
Rate of oxygen uptake
Patients that need oxygen therapy/All patients in that group
Time frame: From the day of intoxication to death or the 60th day.
Rate of mechanical ventilation
Patients that need mechanical ventilation/All patients in that group
Time frame: From the day of intoxication to death or the 60th day.
In-hospital length of stay
Day count from admission to discharge or the end of follow up.
Time frame: From the day of admission to discharge or up to 60 days after admission.
3-day all-cause mortality
Mortality=Dead patients/All patients in that group
Time frame: From the day of intoxication to the 3rd day afterwards.
7-day all-cause mortality
Mortality=Dead patients/All patients in that group
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Time frame: From the day of intoxication to the 7th day afterwards.
60-day all-cause mortality
Mortality=Dead patients/All patients in that group
Time frame: From the day of intoxication to the 60th day afterwards.
ICU length of stay
Day count spent in intensive care unit
Time frame: From the day of intoxication to death or the 60th day.
Rate of catheter related complications
Complications due to catheterization, e.g. thrombocytopenia, deep venous thrombosis, catheter related infection.
Time frame: From the day of intoxication to death or the 60th day.