NCT05036148

Brief Summary

The Academic centre for Malignant Hyperthermia of Masaryk University (ACMHMU) was established in 2021 in Brno, Czech Republic and consists of four academic departments of Medical Faculty of Masaryk University in two tertiary university hospitals, University Hospital Brno and St. Anne Faculty Hospital. These departments collaborated and operated since 2002 and since 2019 is Brno one of the of centre of EMHG (www.emhg.org). Aim of this study was to describe the Czech and Slovak (CZ-SK) cohort of MHS patients, the biggest Slavonic MHS cohort known by now, and to fill the knowledge gap about the Slavonic population in perspective of MH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

July 27, 2021

Last Update Submit

April 14, 2022

Conditions

Keywords

Malignant Hyperthermia

Outcome Measures

Primary Outcomes (1)

  • prevalence of MH in our cohort of patients

    Data registry will be screened for positive MH results

    20 years retrospectively

Secondary Outcomes (2)

  • prevalence of occurrence diagnostic variants in MHS group of patients.

    20 years retrospectively

  • prevalence of each found diagnostic variant in our Czech-and-Slovak cohort of patients.

    20 years retrospectively

Study Arms (1)

Patients indicated for MH screening

Patients referred to MH center for MH diagnostic

Other: Data analysis

Interventions

MH registry data will be screened for MH positive diagnosis

Patients indicated for MH screening

Eligibility Criteria

Age1 Month - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient indiaceted to MH centre for MH diagnostic

You may qualify if:

  • Patients indicated to MH center for MH diagnostic

You may not qualify if:

  • conditions clearly not related to MH, e.g. neuromuscular diseases
  • syndromes without MH risk; anaesthetic complications without MH symptoms, e.g. prolongated awakening due to deficit of cholinesterase
  • probands with missing data
  • probands with yet not closed MH diagnostic process (waiting for genetics or IVCT, myopatic patients without MH diagnostic variant where the IVCT was not recommended because of its invasivity)
  • non-compliant probands, who refused the diagnostic process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

Malignant Hyperthermia

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsHyperthermiaBody Temperature ChangesSigns and Symptoms

Study Officials

  • Petr Stourac, prof. MD., Ph.D.

    Department of paediatric anaesthesia and intensive care

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 27, 2021

First Posted

September 5, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations