Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults

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

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.

Study Overview

• Status: Unknown
• Conditions: Poisoning
• Intervention / Treatment: Procedure: Hemodialysis; Procedure: Hemoperfusion; Procedure: HP-HD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemodialysis (HD); Patients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy.	Procedure: Hemodialysis; Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.
Experimental: Hemoperfusion (HP); Patients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy.	Procedure: Hemoperfusion; Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.
Experimental: HP-HD; Patients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy.	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.
No Intervention: Conservative; Patients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 28th day afterwards.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival time	Live day count.	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	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	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	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.	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	From the day of intoxication to the 3rd day afterwards.
7-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 7th day afterwards.
60-day all-cause mortality	Mortality=Dead patients/All patients in that group	From the day of intoxication to the 60th day afterwards.
ICU length of stay	Day count spent in intensive care unit	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.	From the day of intoxication to death or the 60th day.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: National Natural Science Foundation of China; The First Affiliated Hospital of Zhengzhou University
• Investigators: Study Chair: Yi Li, M.D., Peking Union Medical College Hospital; Study Director: Yanxia Gao, the First Affiliated Hospital of Zhengzhou University

Publications and helpful links

General Publications

• 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. Erratum In: BMJ Open. 2018 Sep 4;8(9):e021964corr1.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 15, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Hemoperfusion; Renal Dialysis; Paraquat
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: HeSAPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No