A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

December 13, 2022 updated by: Children's Hospital Medical Center, Cincinnati
The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia.

Study Overview

Status

Withdrawn

Conditions

Detailed 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases are selected from the medical records at Cincinnati Children's Hospital Medical Center who have a current malignant hyperthermia diagnosis. Control cases are selected based on previous participation in pharmacogenetic research and had exposure to agents known to trigger malignant hyperthermic episodes.

Description

Inclusion Criteria:

  • Malignant hyperthermia cases: Diagnosis of malignant hyperthermia
  • Control cases: children who participated

Exclusion Criteria:

  • Not meeting the inclusion criteria stated above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Malignant Hyperthermia
Samples from persons who have a malignant hyperthermia diagnosis.
Controls
Children who participated in pharmacogenetic research and had exposure to malignant hyperthermia triggering agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of clinical manifestations of malignant hyperthermia
Time Frame: Within data collection period (3 years total).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of Genetic indications for malignant hyperthermia
Time Frame: Within data collection period (3 years total).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: John McAuliffe, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-2884

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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