Poison;MedicinalNCT05762029
Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
An observational study of Poison;Medicinal and Extracorporeal Membrane Oxygenation, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
This is a prospective, multicentre clinical study to determine the value of the Extracorporeal Membrane Oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the prognosis of different types or doses of poison/drug poisoning. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Poison;Medicinal, Extracorporeal Membrane Oxygenation
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2022to 26 Nov 2025
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.
Who may be able to join
- Severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.
- Denying other available methods.
- Indications for the use of the Extracorporeal membrane oxygenation exist.
Who cannot join
- Severely impaired state of consciousness prior to cardiac arrest;
- Multiple organ dysfunction;
- Uncontrolled traumatic bleeding, massive gastrointestinal bleeding, and active intracranial hemorrhage;
- Left ventricular thrombosis; Severe aortic insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Zhongwei Huang, Master, 15335051939, HZW889@163.com
About this study
This is a prospective, multicentre clinical study to determine the value of the Extracorporeal Membrane Oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the prognosis of different types or doses of poison/drug poisoning. These conclusions may guide us on how to correctly perform Extracorporeal Membrane Oxygenation, including whether or when should this treatment enabled, the mode of Extracorporeal Membrane Oxygenation, whether to combine blood purification, treatment schedule and disembarkation time.
Read the detailed description
This study will be conducted in the Affiliated Hospital of Nantong University, the Sixth People's Hospital of Nantong University, the Branch of Affiliated Hospital of Nantong University, the People's Hospital of Qidong City, the People's Hospital of Rudong County, the People's Hospital of Rugao City, and the People's Hospital of Hai 'an City. It is expected that 60 patients with poisoning will be included, and the blood and urine samples of 60 patients will be collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record will be established.
The purpose of this prospective multicenter observational clinical study was to 1) investigate the value of Extracorporeal Membrane Oxygenation in the treatment of fatal poisoning; 2) To investigate the changes of patients' organ functions (heart, lung, liver, kidney, brain) during the Extracorporeal Membrane Oxygenation operation and the influence on the removal of toxins. In order to obtain a more powerful clinical basis to guide the rational use of the Extracorporeal Membrane Oxygenation technology in patients with fatal poisoning.
- Keywords
- Severe poisoning, Extracorporeal Membrane Oxygenation, Emergency medical care
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Due to respiratory and circulatory failure caused by acute server poisoning, patients accepting extracorporeal membrane oxygenation for treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate
Death rate is used to assess the treatment capacity of Extracorporeal membrane oxygenation.
Measured: through study completion, assessed up to 3 year
Complication
Complication is used to assess the side effects of Extracorporeal membrane oxygenation.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Partial pressure of oxygen
PO₂ is used to indicate the state of internal respiration.
Measured: random time before performing extracorporeal membrane oxygenation
Partial pressure of oxygen
PO₂ is used to indicate the state of internal respiration.
Measured: immediately after performing extracorporeal membrane oxygenation
Oxygen saturation
SO₂ is used to indicate the state of internal respiration.
Measured: Before perform the extracorporeal membrane oxygenation
Oxygen saturation
SO₂ is used to indicate the state of internal respiration.
Measured: immediately after performing extracorporeal membrane oxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start26 Nov 2022
- Primary completion26 Nov 2025 (estimated)
- Study completion26 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Poison;MedicinalStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhongwei Huang, Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762029
- Sponsor's protocol ID
- poison ECMO
- Status last verified
- Dec 2022
- First submitted
- 13 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Masson R, Colas V, Parienti JJ, Lehoux P, Massetti M, Charbonneau P, Saulnier F, Daubin C. A comparison of survival with and without extracorporeal life support treatment for severe poisoning due to drug intoxication. Resuscitation. 2012 Nov;83(11):1413-7. doi: 10.1016/j.resuscitation.2012.03.028. Epub 2012 Mar 31.
PubMed 22469751Weiner L, Mazzeffi MA, Hines EQ, Gordon D, Herr DL, Kim HK. Clinical utility of venoarterial-extracorporeal membrane oxygenation (VA-ECMO) in patients with drug-induced cardiogenic shock: a retrospective study of the Extracorporeal Life Support Organizations' ECMO case registry. Clin Toxicol (Phila). 2020 Jul;58(7):705-710. doi: 10.1080/15563650.2019.1676896. Epub 2019 Oct 16.
PubMed 31617764Aso S, Matsui H, Fushimi K, Yasunaga H. In-hospital mortality and successful weaning from venoarterial extracorporeal membrane oxygenation: analysis of 5,263 patients using a national inpatient database in Japan. Crit Care. 2016 Apr 5;20:80. doi: 10.1186/s13054-016-1261-1.
PubMed 27044572Parker BM, Rao T, Matta A, Quitanna M, Reynolds HN, Stein DM, Haase D. Loperamide induced cardiac arrhythmia successfully supported with veno-arterial ECMO (VA-ECMO), molecular adsorbent recirculating system (MARS) and continuous renal replacement therapy (CRRT). Clin Toxicol (Phila). 2019 Nov;57(11):1118-1122. doi: 10.1080/15563650.2019.1580370. Epub 2019 Feb 26.
PubMed 30806091Mohan B, Gupta V, Ralhan S, Gupta D, Puri S, Mahajan R, Goyal A, Chhabra S, Tandon R, Aslam N, Wander GS, Singh B. Impact of extra-corporeal membrane oxygenation on outcome of aluminium phosphide poisoning complicated with myocardial dysfunction. Clin Toxicol (Phila). 2019 Nov;57(11):1095-1102. doi: 10.1080/15563650.2019.1584297. Epub 2019 Mar 11.
PubMed 30856020Tang X, Sun B, He H, Li H, Hu B, Qiu Z, Li J, Zhang C, Hou S, Tong Z, Dai H. Successful extracorporeal membrane oxygenation therapy as a bridge to sequential bilateral lung transplantation for a patient after severe paraquat poisoning. Clin Toxicol (Phila). 2015 Nov;53(9):908-13. doi: 10.3109/15563650.2015.1082183. Epub 2015 Aug 28.
PubMed 26314316
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
- ClinicalTrials.gov ID
- NCT05762029
- Acronym / sponsor ID
- poison ECMO
- Keywords
- Severe poisoning, Extracorporeal Membrane Oxygenation, Emergency medical care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 26 Nov 2025 (estimated)
- Study completion
- 26 Nov 2025 (estimated)
- First posted
- 9 Mar 2023 (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.
This is a prospective, multicentre clinical study to determine the value of the Extracorporeal Membrane Oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the prognosis of different types or doses of poison/drug poisoning. These conclusions may guide us on how to correctly perform Extracorporeal Membrane Oxygenation, including whether or when should this treatment enabled, the mode of Extracorporeal Membrane Oxygenation, whether to combine blood purification, treatment schedule and disembarkation time.
Detailed description
This study will be conducted in the Affiliated Hospital of Nantong University, the Sixth People's Hospital of Nantong University, the Branch of Affiliated Hospital of Nantong University, the People's Hospital of Qidong City, the People's Hospital of Rudong County, the People's Hospital of Rugao City, and the People's Hospital of Hai 'an City. It is expected that 60 patients with poisoning will be included, and the blood and urine samples of 60 patients will be collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record will be established.
The purpose of this prospective multicenter observational clinical study was to 1) investigate the value of Extracorporeal Membrane Oxygenation in the treatment of fatal poisoning; 2) To investigate the changes of patients' organ functions (heart, lung, liver, kidney, brain) during the Extracorporeal Membrane Oxygenation operation and the influence on the removal of toxins. In order to obtain a more powerful clinical basis to guide the rational use of the Extracorporeal Membrane Oxygenation technology in patients with fatal poisoning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Due to respiratory and circulatory failure caused by acute server poisoning, patients accepting extracorporeal membrane oxygenation for treatment. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.
Key inclusion criteria (3 listed)
- Severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.
- Denying other available methods.
- Indications for the use of the Extracorporeal membrane oxygenation exist.
Key exclusion criteria (4 listed)
- Severely impaired state of consciousness prior to cardiac arrest;
- Multiple organ dysfunction;
- Uncontrolled traumatic bleeding, massive gastrointestinal bleeding, and active intracranial hemorrhage;
- Left ventricular thrombosis; Severe aortic insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death rate
Time frame: through study completion, assessed up to 3 year
Death rate is used to assess the treatment capacity of Extracorporeal membrane oxygenation.
Complication
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Complication is used to assess the side effects of Extracorporeal membrane oxygenation.
Partial pressure of oxygen
Time frame: random time before performing extracorporeal membrane oxygenation
PO₂ is used to indicate the state of internal respiration.
Partial pressure of oxygen
Time frame: immediately after performing extracorporeal membrane oxygenation
PO₂ is used to indicate the state of internal respiration.
Oxygen saturation
Time frame: Before perform the extracorporeal membrane oxygenation
SO₂ is used to indicate the state of internal respiration.
Oxygen saturation
Time frame: immediately after performing extracorporeal membrane oxygenation
SO₂ is used to indicate the state of internal respiration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 22469751Masson R, Colas V, Parienti JJ, Lehoux P, Massetti M, Charbonneau P, Saulnier F, Daubin C. A comparison of survival with and without extracorporeal life support treatment for severe poisoning due to drug intoxication. Resuscitation. 2012 Nov;83(11):1413-7. doi: 10.1016/j.resuscitation.2012.03.028. Epub 2012 Mar 31.
- Background: PubMed 31617764Weiner L, Mazzeffi MA, Hines EQ, Gordon D, Herr DL, Kim HK. Clinical utility of venoarterial-extracorporeal membrane oxygenation (VA-ECMO) in patients with drug-induced cardiogenic shock: a retrospective study of the Extracorporeal Life Support Organizations' ECMO case registry. Clin Toxicol (Phila). 2020 Jul;58(7):705-710. doi: 10.1080/15563650.2019.1676896. Epub 2019 Oct 16.
- Background: PubMed 27044572Aso S, Matsui H, Fushimi K, Yasunaga H. In-hospital mortality and successful weaning from venoarterial extracorporeal membrane oxygenation: analysis of 5,263 patients using a national inpatient database in Japan. Crit Care. 2016 Apr 5;20:80. doi: 10.1186/s13054-016-1261-1.
- Background: PubMed 30806091Parker BM, Rao T, Matta A, Quitanna M, Reynolds HN, Stein DM, Haase D. Loperamide induced cardiac arrhythmia successfully supported with veno-arterial ECMO (VA-ECMO), molecular adsorbent recirculating system (MARS) and continuous renal replacement therapy (CRRT). Clin Toxicol (Phila). 2019 Nov;57(11):1118-1122. doi: 10.1080/15563650.2019.1580370. Epub 2019 Feb 26.
- Background: PubMed 30856020Mohan B, Gupta V, Ralhan S, Gupta D, Puri S, Mahajan R, Goyal A, Chhabra S, Tandon R, Aslam N, Wander GS, Singh B. Impact of extra-corporeal membrane oxygenation on outcome of aluminium phosphide poisoning complicated with myocardial dysfunction. Clin Toxicol (Phila). 2019 Nov;57(11):1095-1102. doi: 10.1080/15563650.2019.1584297. Epub 2019 Mar 11.
- Background: PubMed 26314316Tang X, Sun B, He H, Li H, Hu B, Qiu Z, Li J, Zhang C, Hou S, Tong Z, Dai H. Successful extracorporeal membrane oxygenation therapy as a bridge to sequential bilateral lung transplantation for a patient after severe paraquat poisoning. Clin Toxicol (Phila). 2015 Nov;53(9):908-13. doi: 10.3109/15563650.2015.1082183. Epub 2015 Aug 28.
- related informationLink provided by the sponsor.
Related trials for Poison;Medicinal
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
Not yet recruitingObservational study
Real World Asparaginase Therapy Toxicity
Drug Toxicity
Not yet recruiting
Early Addiction Care Pathway After Acute Drug Intoxication in Emergency Departments
Intoxication; Opioid
RecruitingObservational study
TDM for Optimized Outcome in Patients With mRCC.
Kidney Cancer, Renal Cell Carcinoma Metastatic
RecruitingObservational study
Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
ALL, Childhood, Pediatric Cancer
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.
Zhongwei Huang study chair
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poison;Medicinal and Extracorporeal Membrane Oxygenation, run by Affiliated Hospital of Nantong University at 1 site in China.
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 3 inclusion and 4 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zhongwei Huang, Master (15335051939, HZW889@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death rate (time frame: through study completion, assessed up to 3 year). The study lists 6 primary outcomes in all. 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 NCT05762029, which also lists 6 linked publications.
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 9 Mar 2023.