A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia

NCT02561598 | Withdrawn

• 1 other identifier: 2014-2884
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Hyperthermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of Genetic indications for malignant hyperthermia

  Within data collection period (3 years total).

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples from other approved projects will be used from both malignant hyperthermia cases and controls.

MeSH Terms

Conditions

Malignant Hyperthermia

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Hyperthermia; Body Temperature Changes; Signs and Symptoms

Study Officials

• John McAuliffe, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: September 28, 2015
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

US (1)