Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation; Poison;Medicinal

• Registration Number: NCT05762029
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Study Start: 2022-11-26
• Status Verified: 2022-12
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Primary Completion: 2025-11-26
• Study Completion: 2025-11-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death rate	through study completion, assessed up to 3 year	Death rate is used to assess the treatment capacity of Extracorporeal membrane oxygenation.
Complication	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	immediately after performing extracorporeal membrane oxygenation	PO₂ is used to indicate the state of internal respiration.
Oxygen saturation	immediately after performing extracorporeal membrane oxygenation	SO₂ is used to indicate the state of internal respiration.

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China