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Recruiting NCT04837625

Study of Myasthenic Crisis in China

Observational Myasthenia Gravis Myasthenic Crisis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no interventions.
Who it may be relevant to
Registry conditions: Myasthenia Gravis, Myasthenic Crisis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Multicenter Prospective Registration Study of Myasthenic Crisis in China

Overview

This study is a multicenter, prospective, observational research. It will register the basic demographic information, medical history characteristics, clinical features, auxiliary examinations, treatment, outcomes of tracheal intubation/ventilator related events, and clinical outcomes of Myasthenic Crisis patients. The objectives including: 1. Obtain epidemiological data of MC in China; 2. Establish a standardized registration system for MC patients in China; 3. Explore the epidemiology, clinical characteristics, serological characteristics, clinical characteristics of MC, predisposing and predictive factors, extubation process/time, weaning/extubation outcome and predictors of clinical outcome in Chinese MC patients.

Interventions

  • Other no interventions
    no interventions

Primary outcome measures

  • MG-ADL of 3 years after off-mechanical ventilation [Time frame: Sep,2026]

Eligibility criteria

Inclusion criteria

  • clinical history and signs of fluctuating weakness and fatigability;
  • seropositivity forAChR/MuSKantibodies;
  • If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required;
  • Crisis: a serious, life-threatening, rapid worsening of MG requiring intubation or noninvasive ventilation to avoid intubation.
  • Impending crisis: rapid clinical worsening of MG that, in the opinion of the treating physician, could lead to crisis in the short term (days to weeks) with blood gases suggest hypoxia (oxygen saturation <95%) or elevated carbon dioxide (paco2>50mmHg).

Exclusion criteria

  • the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG.
  • except when intubation or noninvasive ventilation are employed during routine postoperative management.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Huashan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT04837625 · MC2020883

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗