Study of Myasthenic Crisis in China

Myasthenia Gravis Clinical Trial

Official title:

A Multicenter Prospective Registration Study of Myasthenic Crisis in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837625
• Other study ID #: MC2020883
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: September 30, 2026

Study information

• Verified date: September 2023
• Source: Huashan Hospital
• Contact: Xiao Huan, MD
• Phone: +8618351973910
• Email: hx941223[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myasthenia Gravis
• Myasthenic Crisis

Intervention

Other:
• no interventions
no interventions

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MG-ADL of 3 years after off-mechanical ventilation		Sep,2026