Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05762029
Collaborator
(none)
60
1
36
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
    Actual Study Start Date :
    Nov 26, 2022
    Anticipated Primary Completion Date :
    Nov 26, 2025
    Anticipated Study Completion Date :
    Nov 26, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Group A

    Due to respiratory and circulatory failure caused by acute server poisoning, patients accepting extracorporeal membrane oxygenation for treatment.

    Outcome Measures

    Primary Outcome Measures

    1. Death rate [through study completion, assessed up to 3 year]

      Death rate is used to assess the treatment capacity of Extracorporeal membrane oxygenation.

    2. 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.

    3. Partial pressure of oxygen [random time before performing extracorporeal membrane oxygenation]

      PO₂ is used to indicate the state of internal respiration.

    4. Partial pressure of oxygen [immediately after performing extracorporeal membrane oxygenation]

      PO₂ is used to indicate the state of internal respiration.

    5. Oxygen saturation [Before perform the extracorporeal membrane oxygenation]

      SO₂ is used to indicate the state of internal respiration.

    6. Oxygen saturation [immediately after performing extracorporeal membrane oxygenation]

      SO₂ is used to indicate the state of internal respiration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Hospital of Nantong University Nantong Jiangsu China 226000

    Sponsors and Collaborators

    • Affiliated Hospital of Nantong University

    Investigators

    • Study Chair: Zhongwei Huang, Affiliated Hospital of Nantong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Affiliated Hospital of Nantong University
    ClinicalTrials.gov Identifier:
    NCT05762029
    Other Study ID Numbers:
    • poison ECMO
    First Posted:
    Mar 9, 2023
    Last Update Posted:
    Mar 9, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Affiliated Hospital of Nantong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2023