Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults

Poisoning Clinical Trial

Official title:

The Efficacy of Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults: Study Protocol for a Randomized Controlled Trial (HeSAPP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03314909
• Other study ID #: HeSAPP
• Status: Not yet recruiting
• Phase: N/A
• First received: October 10, 2017
• Last updated: April 12, 2018
• Start date: October 1, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2018
• Source: Peking Union Medical College Hospital
• Contact: Yi Li, M.D.
• Phone: +86-13693109826
• Email: billliyi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poisoning

Intervention

Procedure:
• Hemodialysis
Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.
• Hemoperfusion
Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Natural Science Foundation of China, The First Affiliated Hospital of Zhengzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 28th day afterwards.
Secondary	Survival time	Live day count.	From the day of intoxication to death or the 60th day.
Secondary	Rate of multiple organ failure	Patients that develop multiple organ failure/All patients in that group	From the day of intoxication to death or the 60th day.
Secondary	Rate of oxygen uptake	Patients that need oxygen therapy/All patients in that group	From the day of intoxication to death or the 60th day.
Secondary	Rate of mechanical ventilation	Patients that need mechanical ventilation/All patients in that group	From the day of intoxication to death or the 60th day.
Secondary	In-hospital length of stay	Day count from admission to discharge or the end of follow up.	From the day of admission to discharge or up to 60 days after admission.
Secondary	3-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 3rd day afterwards.
Secondary	7-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 7th day afterwards.
Secondary	60-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 60th day afterwards.
Secondary	ICU length of stay	Day count spent in intensive care unit	From the day of intoxication to death or the 60th day.
Secondary	Rate of catheter related complications	Complications due to catheterization, e.g. thrombocytopenia, deep venous thrombosis, catheter related infection.	From the day of intoxication to death or the 60th day.