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A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

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ClinicalTrials.gov Identifier: NCT02561598
Recruitment Status : Recruiting
First Posted : September 28, 2015
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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

Condition or disease
Malignant Hyperthermia

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
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia
Study Start Date : May 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Samples from other approved projects will be used from both malignant hyperthermia cases and controls.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not meeting the inclusion criteria stated above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561598


Contacts
Contact: Senthilkumar Sadhasivam, MD, MPH senthilkumar.sadhasivam@cchmc.org
Contact: Kristi Barnett 513-636-5983 kristi.barnett@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Senthilkumar Sadhasivam, MD, MPH    513-636-4408    senthilkumar.sadhasivam@cchmc.org   
Contact: Kristi Barnett    5136365983    kristi.barnett@cchmc.org   
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02561598     History of Changes
Other Study ID Numbers: 2014-2884
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Fever
Malignant Hyperthermia
Body Temperature Changes
Signs and Symptoms
Intraoperative Complications
Pathologic Processes
Postoperative Complications