Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Intracerebral Hemorrhage Clinical Trial

— SNICH  

Official title:

Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078037
• Other study ID #: 13-1407
• Status: Completed
• Phase: Phase 0
• First received: February 21, 2014
• Last updated: January 6, 2017
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Device:
• Arctic Sun cooling device
The Arctic Sun® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group.

Other:
• Standard of Care
Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients	Cytokine markers of inflammation tested daily over the first five days of the study in control ICH patients to determine the natural inflammation history of ICH.	5 days	No
Other	Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS)	Berlin classification for mild adult respiratory distress syndrome (previously ALI) and adult respiratory distress syndrome (ARDS). Centers for Disease Control and Prevention (CDC) definitions for pneumonia and sepsis.	First 10 days of hospital stay	Yes
Primary	MRI measurement of relative perihematomal edema (% change of perihematomal edema)	Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI	First 5 days of hospital course	No
Secondary	Structured telephone interview of functional and cognitive outcome	Functional and cognitive outcomes measured by structured phone assessment.	3 months and 1 year	No
Secondary	Serum cytokine measurement with inflammatory cytokine protein array	Cytokine markers of inflammation tested daily over the first 5 days.	5 days	No