Systemic Normothermia in Intracerebral Hemorrhage (ICH)
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/7/2015 |
| Start Date: | March 2014 |
| End Date: | March 2016 |
| Contact: | Javier J Provencio, MD |
| Email: | provenj@ccf.org |
| Phone: | 216-445-2423 |
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.
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.
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.
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.
Inclusion Criteria:
1. Patients with spontaneous supratentorial ICH >20 cc
2. Age 18 to 85 years of age
3. Consent from the patient or surrogate decision maker
4. Within 24 hours of onset of ictus
Exclusion Criteria:
1. Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or
Arterio-venous dural fistula
2. Moribund state and deemed unlikely to survive until study completion (5 days)
3. Patients with a don-not-resuscitate (DNR) order
4. Known infection at the time of admission (elevated white blood cell count (WBC) with
identified infection source).
5. Evidence of a blood dyscrasia
6. Pregnancy
7. Renal failure (CCR < 50 ml/min)
8. Contraindications for a brain MRI scan
9. Infratentorial ICH
10. Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized
Ratio (INR) < 1.4 within 24 hours
11. Episode of fever > 38.5 degrees Celsius prior to enrollment
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