Clinical trial NCT03314909: Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults
Official title: The Efficacy of Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults: Study Protocol for a Randomized Controlled Trial (HeSAPP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poisoning
Keywords: Renal Dialysis
Hemoperfusion
Paraquat
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: National Natural Science Foundation of China
First posted: 2017-10-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 28-day all-cause mortality
timeFrame: From the day of intoxication to the 28th day afterwards.
Secondary outcomes:
measure: Survival time
timeFrame: From the day of intoxication to death or the 60th day.
measure: Rate of multiple organ failure
timeFrame: From the day of intoxication to death or the 60th day.
measure: Rate of oxygen uptake
timeFrame: From the day of intoxication to death or the 60th day.
measure: Rate of mechanical ventilation
timeFrame: From the day of intoxication to death or the 60th day.
measure: In-hospital length of stay
timeFrame: From the day of admission to discharge or up to 60 days after admission.
measure: 3-day all-cause mortality
timeFrame: From the day of intoxication to the 3rd day afterwards.
measure: 7-day all-cause mortality
timeFrame: From the day of intoxication to the 7th day afterwards.
measure: 60-day all-cause mortality
timeFrame: From the day of intoxication to the 60th day afterwards.
measure: ICU length of stay
timeFrame: From the day of intoxication to death or the 60th day.
measure: Rate of catheter related complications
timeFrame: From the day of intoxication to death or the 60th day.
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yi Li, M.D.
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Yanxia Gao
role: STUDY_DIRECTOR
References:
citation: Cui JW, Xu Y, Wang Y, Gao YX, Guo S, Wang M, Lu X, Yu S, Ma Y, Yuan D, Che L, Sun P, Yu X, Zhu H, Li Y. Efficacy of initial haemopurification strategy for acute paraquat poisoning in adults: study protocol for a randomised controlled trial (HeSAPP). BMJ Open. 2018 Jun 22;8(6):e021964. doi: 10.1136/bmjopen-2018-021964.