Clinical Trials Logo
  1. Home
  2. Rhabdomyolysis
  3. NCT04610619

Multisystem Features of Malignant Hyperthermia or Rhabdomyolysis Related to RYR1 Variants

Rhabdomyolysis Clinical Trial

Official title:
The Neuromuscular and Multisystem Features of RYR1-related Malignant Hyperthermia and Rhabdomyolysis - a Study Protocol

Clinical Trial Summary

Rationale: Malignant hyperthermia and rhabdomyolysis are phenotypes that have long been considered to occur only in response to external stimuli (trigger anaesthesia and physical exhaustion) show several features of a continuous disease manifestation. Previous studies showed prolonged bleeding time after injury, selective immunological advantages, axial muscle weakness and several social difficulties. A detailed study of the neuromuscular and multisystem features of patients with RYR1-related malignant hyperthermia or rhabdomyolysis is needed to provide clarification about the continuous and multisystem disease manifestations in these patients. Objective: Primary Objective: There are three primary objectives in this study. 1. To investigate the neuromuscular involvement of RYR1 related MH and rhabdomyolysis. 2. To investigate the immunological changes in subjects with RYR1 related MH and rhabdomyolysis. 3. To identify multisystem features of RYR1 related MH and rhabdomyolysis. There are no secondary objectives. Study design: The design of the study will be a clinical, open, observational study. The study consists of three parts; a clinical, imaging and immunological part. Study population: Patients with a history of malignant hyperthermia susceptibility (MHS), and/or a history of rhabdomyolysis related to a variant in RYR1. Intervention (if applicable): Not applicable. Main study parameters/endpoints: The study consists of three parts. Each part has it's own main study parameters 1. Clinical part: the results of the questionnaire study compared to standardizes normal values and the results of the comprehensive clinical assessment. 2. Imaging part: fatty infiltration and hypertrophy of proximal and axial muscles. 3. Immunological part: circulating and leukocyte released anti- and pro-inflammatory cytokine levels compared to healthy age and sex matched controls.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04610619
Study type Observational [Patient Registry]
Source Radboud University
Contact
Status Recruiting
Phase
Start date August 19, 2020
Completion date January 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03737513 - Exercise-induced Collective Rhabdomyolysis
Completed NCT00241748 - Pharmacoepidemiology and Pharmacogenetics of a Statin Adverse Event N/A
Not yet recruiting NCT02498366 - Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty N/A
Not yet recruiting NCT06429982 - Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols Phase 1
Active, not recruiting NCT06101680 - RhabdomYolyse in Intensive caRe
Withdrawn NCT02896517 - Support for the Rhabdomyolysis in an Emergency Department
Completed NCT01467180 - Myoglobin Removal by High Cut-off CVVHD N/A
Recruiting NCT01022450 - Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients N/A
Completed NCT00391911 - Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis Phase 2
Withdrawn NCT02111018 - Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis Phase 2
Completed NCT04913298 - Prospective Study for the Application of Cytosorb® in Critically Ill Patients N/A
Recruiting NCT05146336 - CytOSorb TreatMent Of Critically Ill PatientS Registry
Completed NCT03986736 - Markers of Tissue Injury and Rhabdomyolysis in Patients With Major Trauma
Not yet recruiting NCT02518724 - The Effect of Remote Ischemic Preconditioning on Physical Performance and Exertional Rhabdomyolysis N/A
Completed NCT02671604 - Rhabdomyolysis and Robot-assisted Radical Prostatectomy N/A
Completed NCT00592657 - Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions N/A
Completed NCT06338423 - Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure N/A
Completed NCT01976936 - Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2 Phase 2
Completed NCT04118608 - Rhabdomyolysis - a Study of Patient Characteristics and Laboratory Values to Guide Treatment
Completed NCT01544231 - Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis N/A