Clinical trial NCT05762029: Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
Official title: Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Poison;Medicinal
Extracorporeal Membrane Oxygenation
Keywords: Severe poisoning
Extracorporeal Membrane Oxygenation
Emergency medical care
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Death rate
timeFrame: through study completion, assessed up to 3 year
measure: Complication
timeFrame: 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
measure: Partial pressure of oxygen
timeFrame: random time before performing extracorporeal membrane oxygenation
measure: Partial pressure of oxygen
timeFrame: immediately after performing extracorporeal membrane oxygenation
measure: Oxygen saturation
timeFrame: Before perform the extracorporeal membrane oxygenation
measure: Oxygen saturation
timeFrame: immediately after performing extracorporeal membrane oxygenation
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Zhongwei Huang
role: STUDY_CHAIR
References:
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citation: Weiner 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.
citation: Aso 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.
citation: Parker 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.
citation: Mohan 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.
citation: Tang 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.