Caffeinol Hypothermia Protocol

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00299416
First received: March 2, 2006
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Drug: Caffeinol
Procedure: hypothermia
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Number of Participants With Symptomatic Intracerebral Hemorrhage [ Time Frame: from pre-dosage to 90 day followup ] [ Designated as safety issue: Yes ]
    Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)

  • Number of Participants With Catheter Related Complications During Hypothermia & Rewarming [ Time Frame: over 36 hour period ] [ Designated as safety issue: Yes ]
    Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.

  • Number of Participants With Cardiorespiratory Failure [ Time Frame: every 30 minutes during hypothermia induction ] [ Designated as safety issue: Yes ]
    The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.


Secondary Outcome Measures:
  • Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming, [ Time Frame: rewarming over 12 hours until 36.5C has been achieved ] [ Designated as safety issue: No ]
    Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.

  • Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering. [ Time Frame: rewarming over 12 hours until 36.5C has been achieved ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.


Enrollment: 30
Study Start Date: February 2003
Study Completion Date: August 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Caffeinol
    Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.
    Procedure: hypothermia
    External or internal cooling for 24 hours and rewarming over 12 hours.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 years
  2. Clinical presentation of acute ischemic stroke
  3. Computed tomography (CT) scan compatible with acute ischemic stroke.
  4. Time to caffeinol treatment < 240 minutes from stroke onset.
  5. Time to hypothermia initiation < 300 minutes from stroke onset.
  6. Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut)
  7. National Institutes of Health Stroke Scale (NIHSS) > 8 at time of each treatment.
  8. Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA.

Exclusion Criteria:

  1. Etiology other than ischemic stroke.
  2. Item 1a on NIHSS > 1
  3. Signs/symptoms of subcortical, brainstem or cerebellar stroke.
  4. Symptoms resolving or NIHSS < 8 at time of each treatment.
  5. NIHSS > 20 if right hemisphere or >25 if left hemisphere
  6. Known alcoholic
  7. Clinical or laboratory evidence of alcohol intoxication.
  8. Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks.
  9. Known hematologic dyscrasias that affect thrombosis.
  10. Comorbid conditions likely to complicate therapy:

    1. End-stage cardiomyopathy
    2. Uncompensated or clinically significant arrhythmia
    3. Myopathy
    4. Liver disease
    5. History of pelvic or abdominal mass likely to compress inferior vena cava.
    6. End-stage AIDS
    7. History of clinically significant gastrointestinal (GI) bleeding
    8. Impaired renal function with creatinine clearance, 50 ml/min
  11. Intracerebral / intraventricular hemorrhage
  12. Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 100 or < 50 mmHg
  13. Severe coagulopathy
  14. Pregnancy
  15. Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks
  16. Known history of epilepsy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299416

Locations
United States, Texas
Memorial Hermann Hospital - Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: James C. Grotta, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: James C. Grotta, MD-, UT- Houston Health Science Center, Department of Neurology
ClinicalTrials.gov Identifier: NCT00299416     History of Changes
Other Study ID Numbers: HSC- MS-02-188, P50NS44277 project #1
Study First Received: March 2, 2006
Results First Received: August 16, 2010
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Stroke
Nonhemorrhagic
hypothermia

Additional relevant MeSH terms:
Hypothermia
Ischemia
Stroke
Body Temperature Changes
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014