Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
Exertional Heat Stroke
About this trial
This is an interventional treatment trial for Exertional Heat Stroke
Eligibility Criteria
Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104 degrees F); recent history of exertional activity; GCS score less than 13; tachycardia -
Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition; endotracheal intubation;; sedative drugs administered prior to or at time of study entry; likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant or prior use of calcium channel blockers.
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Sites / Locations
- King Faisal Hospital
- Mina al Jisr Hospital
- Mina Al-Shari Al-Jadeed Hospital
- Mina Al-Wadi Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Ryanodex and Standard of Care
Standard of Care only (SOC)
In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.
Standard of Care treatment will consist of the immediate start of cooling measures.