NCT05762029

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2025

Completed
Last Updated

March 9, 2023

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

February 13, 2023

Last Update Submit

February 27, 2023

Conditions

Poison;MedicinalExtracorporeal Membrane Oxygenation

Keywords

Severe poisoningExtracorporeal Membrane OxygenationEmergency medical care

Outcome Measures

Primary Outcomes (6)

  • Death rate

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

    through study completion, assessed up to 3 year

  • 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

  • Partial pressure of oxygen

    PO₂ is used to indicate the state of internal respiration.

    random time before performing extracorporeal membrane oxygenation

  • Partial pressure of oxygen

    PO₂ is used to indicate the state of internal respiration.

    immediately after performing extracorporeal membrane oxygenation

  • Oxygen saturation

    SO₂ is used to indicate the state of internal respiration.

    Before perform the extracorporeal membrane oxygenation

  • Oxygen saturation

    SO₂ is used to indicate the state of internal respiration.

    immediately after performing extracorporeal membrane oxygenation

Study Arms (1)

Group A

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

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 22469751BACKGROUND

  • 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.

    PMID: 31617764BACKGROUND

  • 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.

    PMID: 27044572BACKGROUND

  • 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.

    PMID: 30806091BACKGROUND

  • 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.

    PMID: 30856020BACKGROUND

  • 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.

    PMID: 26314316BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, urine samples.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsPoisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Zhongwei Huang

    Affiliated Hospital of Nantong University

    STUDY CHAIR

Central Study Contacts

Zhongwei Huang, Master

CONTACT

15335051939HZW889@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 9, 2023

Study Start

November 26, 2022

Primary Completion

November 26, 2025

Study Completion

November 26, 2025

Last Updated

March 9, 2023

Record last verified: 2022-12

Locations

CN(1)