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Clinical Trials/NCT04837625
NCT04837625RecruitingNot Applicable

A Multicenter Prospective Registration Study of Myasthenic Crisis in China

Huashan Hospital1 site in 1 country300 target enrollmentStarted: October 1, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
MG-ADL of 3 years after off-mechanical ventilation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

MG-ADL of 3 years after off-mechanical ventilation

Time Frame: Sep,2026

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chongbo Zhao

Professor

Huashan Hospital

Study Sites (1)

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Study of Myasthenic Crisis in China | Clinical Trial