Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762029
• Other study ID #: poison ECMO
• Status: Recruiting
• Start date: November 26, 2022
• Est. completion date: November 26, 2025

Study information

• Verified date: December 2022
• Source: Affiliated Hospital of Nantong University
• Contact: Zhongwei Huang, Master
• Phone: 15335051939
• Email: HZW889[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 26, 2025
• Est. primary completion date: November 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation
• Poisoning

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rate	Death rate is used to assess the treatment capacity of Extracorporeal membrane oxygenation.	through study completion, assessed up to 3 year
Primary	Complication	Complication is used to assess the side effects of Extracorporeal membrane oxygenation.	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
Primary	Partial pressure of oxygen	PO2 is used to indicate the state of internal respiration.	random time before performing extracorporeal membrane oxygenation
Primary	Partial pressure of oxygen	PO2 is used to indicate the state of internal respiration.	immediately after performing extracorporeal membrane oxygenation
Primary	Oxygen saturation	SO2 is used to indicate the state of internal respiration.	Before perform the extracorporeal membrane oxygenation
Primary	Oxygen saturation	SO2 is used to indicate the state of internal respiration.	immediately after performing extracorporeal membrane oxygenation

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