Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning

February 27, 2023 updated by: Affiliated Hospital of Nantong University
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhongwei Huang, Master
  • Phone Number: 15335051939
  • Email: HZW889@163.com

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Recruiting
        • Affiliated Hospital Of Nantong University
        • Contact:
          • Zhongwei Huang, Master
          • Phone Number: 15335051939
          • Email: HZW889@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, assessed up to 3 year
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.
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
Time Frame: random time before performing extracorporeal membrane oxygenation
PO₂ is used to indicate the state of internal respiration.
random time before performing extracorporeal membrane oxygenation
Partial pressure of oxygen
Time Frame: immediately after performing extracorporeal membrane oxygenation
PO₂ is used to indicate the state of internal respiration.
immediately after performing extracorporeal membrane oxygenation
Oxygen saturation
Time Frame: Before perform the extracorporeal membrane oxygenation
SO₂ is used to indicate the state of internal respiration.
Before perform the extracorporeal membrane oxygenation
Oxygen saturation
Time Frame: immediately after performing extracorporeal membrane oxygenation
SO₂ is used to indicate the state of internal respiration.
immediately after performing extracorporeal membrane oxygenation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2022

Primary Completion (Anticipated)

November 26, 2025

Study Completion (Anticipated)

November 26, 2025

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • poison ECMO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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