Caffeinol Hypothermia Protocol

Completed

Phase 1/2 Results

Trial Description

Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.

Conditions

Interventions

  • Hypothermia Device
    Intervention Desc: External or internal cooling for 24 hours and rewarming over 12 hours.
  • Caffeinol Drug
    Intervention Desc: Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Patient will receive drug, Caffeinol as an infusion(9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. Patient will also undergo hypothermia(external or internal cooling) for 24 hours and rewarming over 12 hours.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety: symptomatic hemorrhage, catheter-related complications, infections, cardiorespiratory failure, arrhythmias.
Secondary Feasibility: time required to reach the target core temperature or lowest tolerated temperature, stability of patient temperature, control of rewarming; achievement of therapeutic serum ethanol and caffeine levels, and amount of sedation needed to suppress shivering; efficacy: NIHSS < 2 at 24 hours, mRS < 2 at 3 months, NIHSS < 2 at 3 months, and length of hospital and ICU stay.
Primary Number of Participants With Symptomatic Intracerebral Hemorrhage from pre-dosage to 90 day followup Yes
Primary Number of Participants With Catheter Related Complications During Hypothermia & Rewarming over 36 hour period Yes
Primary Number of Participants With Cardiorespiratory Failure every 30 minutes during hypothermia induction Yes
Secondary Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming, rewarming over 12 hours until 36.5C has been achieved No
Secondary Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering. rewarming over 12 hours until 36.5C has been achieved Yes
Secondary Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay. 90 days No

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