Clinical Trial: Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Brief Summary: Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.

Detailed Summary: This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.
Sponsor: The Cleveland Clinic

Current Primary Outcome: MRI measurement of relative perihematomal edema (% change of perihematomal edema) [ Time Frame: First 5 days of hospital course ]

Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI


Original Primary Outcome: Primary outcome [ Time Frame: First 5 days of hospital course ]

Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI


Current Secondary Outcome:

  • Structured telephone interview of functional and cognitive outcome [ Time Frame: 3 months and 1 year ]
    Functional and cognitive outcomes measured by structured phone assessment.
  • Serum cytokine measurement with inflammatory cytokine protein array [ Time Frame: 5 days ]
    Cytokine markers of inflammation tested daily over the first 5 days.


Original Secondary Outcome:

  • 3 month and 1 year functional and cognitive outcome [ Time Frame: 3 months and 1 year ]
    Functional and cognitive outcomes measured by structured phone assessment.
  • Inflammation after ICH in control and normothermia patients [ Time Frame: 5 days ]
    Cytokine markers of inflammation tested daily over the first 5 days.


Information By: The Cleveland Clinic

Dates:
Date Received: February 21, 2014
Date Started: March 2014
Date Completion:
Last Updated: January 6, 2017
Last Verified: January 2017