Study of Myasthenic Crisis in China

NCT ID: NCT04837625

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myasthenia Gravis Myasthenic Crisis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myasthenic Crisis Cohort

no interventions

Intervention Type OTHER

no interventions

Interventions

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no interventions

no interventions

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chongbo Zhao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao Huan, MD

Role: CONTACT

+8618351973910

Susan Luo, MD;PHD

Role: CONTACT

Facility Contacts

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Xiao Huan, MD

Role: primary

Susan Luo, MD;PHD

Role: backup

Other Identifiers

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MC2020883

Identifier Type: -

Identifier Source: org_study_id

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