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Study of Myasthenic Crisis in China

A Multicenter Prospective Registration Study of Myasthenic Crisis in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04837625
Enrollment
300
Registered
2021-04-08
Start date
2020-10-01
Completion date
2026-09-30
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis, Myasthenic Crisis

Brief 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.

Interventions

OTHERno interventions

no interventions

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
MG-ADL of 3 years after off-mechanical ventilationSep,2026

Countries

China

Contacts

Primary ContactXiao Huan, MD
hx941223@163.com+8618351973910
Backup ContactSusan Luo, MD;PHD
SusanRo_36@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026