PoisoningNCT03314909
Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults
A study testing Hemodialysis, Hemoperfusion and HP-HD in people with Poisoning, run by Peking Union Medical College Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Poisoning
- What is being tested?
- Hemodialysis, Hemoperfusion and HP-HD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Poisoning
- Being tested
- Hemodialysis, Hemoperfusion, HP-HD
- Keywords
- Renal Dialysis, Hemoperfusion, Paraquat
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisProcedure or surgery
Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.
HemoperfusionProcedure or surgery
Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.
HP-HDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis (HD) | Experimental | Patients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy. Receives: Procedure: Hemodialysis |
| Hemoperfusion (HP) | Experimental | Patients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy. Receives: Procedure: Hemoperfusion |
| HP-HD | Experimental | Patients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy. Receives: Procedure: HP-HD |
| Conservative | No intervention | Patients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Mortality=Dead patients/All patients in that group
Measured: From the day of intoxication to the 28th day afterwards.
Secondary outcomes (10)
Survival time
Live day count.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: From the day of intoxication to the 3rd day afterwards.
7-day all-cause mortality
Mortality=Dead patients/All patients in that group
Measured: From the day of intoxication to the 7th day afterwards.
60-day all-cause mortality
Mortality=Dead patients/All patients in that group
Measured: From the day of intoxication to the 60th day afterwards.
ICU length of stay
Day count spent in intensive care unit
Measured: 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.
Measured: From the day of intoxication to death or the 60th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Oct 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PoisoningStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Yi Li, MD, Peking Union Medical College Hospital
- Investigators
- Yi Li, M.D., Study chair, Peking Union Medical College HospitalYanxia Gao, Study director, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314909
- Sponsor's protocol ID
- HeSAPP
- Status last verified
- Apr 2018
- First submitted
- 10 Oct 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided.
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.
PubMed 29934393
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults: Study Protocol for a Randomized Controlled Trial (HeSAPP)
- ClinicalTrials.gov ID
- NCT03314909
- Acronym / sponsor ID
- HeSAPP
- Conditions
- Poisoning
- Keywords
- Renal Dialysis, Hemoperfusion, Paraquat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, National Natural Science Foundation of China
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis (HD) | Experimental | Procedure: HemodialysisPatients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy. |
| Hemoperfusion (HP) | Experimental | Procedure: HemoperfusionPatients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy. |
| HP-HD | Experimental | Procedure: HP-HDPatients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy. |
| Conservative | No intervention | –Patients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemodialysisParticipants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine. | Procedure or surgery | Hemodialysis (HD) |
| HemoperfusionParticipants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine. | Procedure or surgery | Hemoperfusion (HP) |
| HP-HDParticipants 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. | Procedure or surgery | HP-HD |
Primary outcome
28-day all-cause mortality
Time frame: From the day of intoxication to the 28th day afterwards.
Mortality=Dead patients/All patients in that group
10 secondary outcomes
Survival time
Time frame: From the day of intoxication to death or the 60th day.
Rate of multiple organ failure
Time frame: From the day of intoxication to death or the 60th day.
Rate of oxygen uptake
Time frame: From the day of intoxication to death or the 60th day.
Rate of mechanical ventilation
Time frame: From the day of intoxication to death or the 60th day.
In-hospital length of stay
Time frame: From the day of admission to discharge or up to 60 days after admission.
3-day all-cause mortality
Time frame: From the day of intoxication to the 3rd day afterwards.
7-day all-cause mortality
Time frame: From the day of intoxication to the 7th day afterwards.
60-day all-cause mortality
Time frame: From the day of intoxication to the 60th day afterwards.
ICU length of stay
Time frame: From the day of intoxication to death or the 60th day.
Rate of catheter related complications
Time frame: From the day of intoxication to death or the 60th day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 29934393Cui 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.
- Individual participant dataSharing planned: Undecided. Not decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Li, M.D. study chair
Peking Union Medical College Hospital
Yanxia Gao study director
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis, Hemoperfusion and HP-HD in people with Poisoning, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Li, M.D. (+86-13693109826, billliyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: From the day of intoxication to the 28th day afterwards.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.