Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Serial heart rate measurements |
Heart rate- BPM |
pre drug infusion, 1 minute, 5 minute, 10 minute and 20 minutes post infusion |
|
Other |
Serial Blood pressure measurements |
BP - mmHg |
pre drug infusion,1minute, 5 minute, 10 minute and 20 minutes post drug infusion |
|
Other |
Serial arterial O2 sats |
O2 sats %, percent of Hgb |
pre drug, post drug 1 minute, 5 minute, 10 minute and 20 minutes |
|
Other |
Serial mixed venous O2 sats- measured from PA catheter |
mixed venous O2 sats % percent of Hgb |
pre drug infusion, 1 minute , 5 minute, 10 minute and 20 minutes post drug infusion |
|
Other |
Serial PA measurements |
PA- mmHg |
pre drug infusion , 1 minute, 5 minute, 10 minute and 20 minutes post drug infusion |
|
Other |
Serial Pulmonary Cap. Wedge pressure measurements |
PCWP- mmHg |
pre drug infusion, 1 minute, 5 minute, 10 minute and 20 minutes post drug infusion |
|
Other |
Per the pharmacokinetics measurements that will be collected and measured offline-drug half life |
half-life (h) |
post drug infusion at 5 minutes,10 minutes,15 minutes, 20 minutes, 1-4 hours, 6-12 hours,16-24 hours and optional 28-36 hours |
|
Other |
Maximum observed plasma concentration |
Cmax (ng/ml) |
Post drug infusion at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 1-4 hours, 6-12 hours,16-24 hours and optional 28-36 hours |
|
Other |
Time to reach maximum observed plasma concentration |
Tmax (h) |
Post drug infusion at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 1-4 hours, 6-12 hours,16-24 hours and optional 28-36 hours |
|
Other |
Area under the concentration-time curve from zero to infinity |
AUC- h ng/ml |
post drug infusion at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 1-4 hours, 6-12 hours,16-24 hours and optional 28-36 hours |
|
Other |
Ventricular effective refractory period pre/post Dantrolene |
VERP measured at 500 ms |
pre-drug infusion, post drug infusion at 5 minutes, 10 minutes,15 minutes and 20 minute post-drug |
|
Other |
Oxygen Saturation |
Oxygen saturation measured by pulse oximeter, % |
pre-procedure, during procedure |
|
Other |
Respiratory Rate |
Rate of respiration, respiration per minute |
pre-procedure, during procedure |
|
Other |
Minute Ventilation |
Ventilator measured L/min of ventilation |
during procedure |
|
Other |
Tidal Volume |
Volume of ventilated air, measured as L/breath |
during procedure |
|
Other |
Arterial Blood Gas - pH |
Blood gas, obtained from arterial blood supply, pH measurement |
pre-procedure, during procedure, two hours post procedure |
|
Other |
Arterial Blood Gas - pO2 |
Blood gas, obtained from arterial blood supply, mmHg of O2 concentration |
Pre-procedure, during procedure, two hours post procedure |
|
Other |
Arterial Blood Gas - pCO2 |
Blood gas, obtained from arterial blood supply, mmHg of CO2 concentration |
pre-procedure, during procedure, two hours post procedure |
|
Other |
Arterial Blood Gas - base excess |
Blood gas, obtained from arterial blood supply, mmHg of CO2 concentration |
pre-procedure, during procedure, two hours post procedure |
|
Other |
Muscle Strength |
Handgrip strength using a dynamometer; measured in pounds of force |
pre-procedure, two hours post procedure |
|
Other |
Neuromuscular twitch height |
Twitch amplitude; measured as a % of the baseline calibration twitch amplitude (unitless, % change) |
During procedure, post drug infusion at 0, 5, 10, 15, 20 minutes |
|
Other |
Respiratory support |
Bag/mask ventilation, CPAP, BiPAP, LMA, or tracheal intubation |
pre-procedure, during procedure, and two hours post procedure |
|
Other |
Negative Inspiratory Force |
measured in cm H20 |
pre-procedure and two hours post procedure |
|
Other |
Neuromuscular train of four |
Train of four stimulation test measured as a % of the fourth stimulation compared to the first (unitless, % change) |
pre-procedure, during procedure, post drug infusion at 0, 5, 10, 15, 20 minutes, and continuous |
|
Other |
Blood chemistry |
Arterial blood concentrations of sodium, chloride, potassium, ionized calcium, bicarbonate, glucose, and lactate measured in SI ) international system of units. |
pre-procedure, during procedure, two hours post procedure |
|
Primary |
Inducibility of sustained VT/VF by standardized ventricular stimulation protocol |
Post drug ventricular stimulation with RV ventricular catheter in the RV apex with increasing extra stimuli with planned decrement stimuli by 10 ms to ERP. Outcome is measured as Ventricular inducibility yes/no. |
10 minutes post drug infusion |
|
Secondary |
Stage of inducibility by standardized ventricular stimulation protocol of the sustained VT/VF |
measured as ordinal variable for stage of ventricular stimulation protocol;specific step by step V-stim research protocol will be followed with single extra stimuli up to six extra stimuli added to VERP. What stage of Inducible VT will be recorded. |
10 minutes post drug infusion |
|