Malignant HyperthermiaNCT02561598
A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia
An observational study of Malignant Hyperthermia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Hyperthermia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Malignant hyperthermia cases: Diagnosis of malignant hyperthermia
- Control cases: children who participated
Who cannot join
- Not meeting the inclusion criteria stated above
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia.
Read the 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.
- Conditions
- Malignant Hyperthermia
- Medical subject headings
- Malignant Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within data collection period (3 years total).
Secondary outcomes (1)
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
Measured: Within data collection period (3 years total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Why it stopped: Research Staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HyperthermiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John McAuliffe, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561598
- Sponsor's protocol ID
- 2014-2884
- Status last verified
- Dec 2022
- First submitted
- 27 Jul 2015
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia
- ClinicalTrials.gov ID
- NCT02561598
- Acronym / sponsor ID
- 2014-2884
- Conditions
- Malignant Hyperthermia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Research Staffing issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to develop methods to identify predictors of 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Malignant hyperthermia cases: Diagnosis of malignant hyperthermia
- Control cases: children who participated
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria stated above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
number of Genetic indications for malignant hyperthermia
Time frame: Within data collection period (3 years total).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John McAuliffe, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Hyperthermia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical manifestations of malignant hyperthermia (time frame: Within data collection period (3 years total).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.