Observational study of Myasthenic Crisis in China
A Multicenter Prospective Registration Study of Myasthenic Crisis in China
This study is trying to collect detailed information about patients in China who experience Myasthenic Crisis to better understand their condition and improve treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04837625 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational study aims to gather comprehensive data on patients experiencing Myasthenic Crisis in China. It will document demographic information, medical history, clinical features, and treatment outcomes related to tracheal intubation and ventilation. The study seeks to establish a standardized registration system for these patients while exploring various epidemiological and clinical characteristics, as well as predictors of clinical outcomes. By analyzing this data, the study aims to enhance understanding of Myasthenic Crisis in the Chinese population.
Who should consider this trial
Good fit: Ideal candidates include individuals with a clinical history of fluctuating weakness and fatigability, seropositivity for AChR/MuSK antibodies, or those at risk of a Myasthenic Crisis.
Not a fit: Patients who do not meet the inclusion criteria or have conditions that mimic Myasthenia Gravis, such as Lambert-Eaton syndrome, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of patients with Myasthenic Crisis in China.
How similar studies have performed: While this study focuses on a specific population and condition, similar observational studies have successfully contributed to understanding Myasthenia Gravis and its complications.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiao Huan, MD
- Email: hx941223@163.com
- Phone: +8618351973910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.