A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

Malignant Hyperthermia Clinical Trial

Official title:

A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02561598
• Other study ID #: 2014-2884
• Status: Withdrawn
• Start date: May 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia.

Description:

The current study will use the combination of electronic medical records and genomic information in samples of persons who have exhibited signs of Malignant Hyperthermia (MH) or have family history or high risk of MH to see if risk factors can be identified. These will be compared with control samples of children who have been exposed to the same agents which could induce MH, yet showed no signs of the disorder.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Malignant hyperthermia cases: Diagnosis of malignant hyperthermia

• Control cases: children who participated

Exclusion Criteria:

• Not meeting the inclusion criteria stated above

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Malignant Hyperthermia

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of clinical manifestations of malignant hyperthermia	Incidence of clinical manifestations of MH will be compared among patients with a history of MH to controls (no diagnosis of MH).	Within data collection period (3 years total).
Secondary	number of Genetic indications for malignant hyperthermia	genetic indications for malignant hyperthermia will be compared between control subjects and subjects with a diagnosis of MH	Within data collection period (3 years total).