Clinical trial NCT02078037: Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Official title: Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral hemorrhage
Perihematomal edema
hemorrhage
normothermia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: MRI measurement of relative perihematomal edema (% change of perihematomal edema)
timeFrame: First 5 days of hospital course
Secondary outcomes:
measure: Structured telephone interview of functional and cognitive outcome
timeFrame: 3 months and 1 year
measure: Serum cytokine measurement with inflammatory cytokine protein array
timeFrame: 5 days
Other outcomes:
measure: Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients
timeFrame: 5 days
measure: Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS)
timeFrame: First 10 days of hospital stay
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Javier J Provencio, MD
role: PRINCIPAL_INVESTIGATOR
References: