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)
1 other identifier
interventional
360
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedApril 17, 2018
April 1, 2018
3.3 years
October 10, 2017
April 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28-day all-cause mortality
Mortality=Dead patients/All patients in that group
From the day of intoxication to the 28th day afterwards.
Secondary Outcomes (10)
Survival time
From the day of intoxication to death or the 60th day.
Rate of multiple organ failure
From the day of intoxication to death or the 60th day.
Rate of oxygen uptake
From the day of intoxication to death or the 60th day.
Rate of mechanical ventilation
From the day of intoxication to death or the 60th day.
In-hospital length of stay
From the day of admission to discharge or up to 60 days after admission.
- +5 more secondary outcomes
Study Arms (4)
Hemodialysis (HD)
EXPERIMENTALPatients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy.
Hemoperfusion (HP)
EXPERIMENTALPatients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy.
HP-HD
EXPERIMENTALPatients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy.
Conservative
NO INTERVENTIONPatients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29934393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yi Li, M.D.
Peking Union Medical College Hospital
- STUDY DIRECTOR
Yanxia Gao
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study is designed as a non-blinded trial because of the apparently different equipment of the interventions
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician of Emergency Department, professor
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 19, 2017
Study Start
October 1, 2018
Primary Completion
December 31, 2021
Study Completion
February 28, 2022
Last Updated
April 17, 2018
Record last verified: 2018-04