None listed
Conditions
Brief summary
The CHIL study hypothesis is that not only will systemic or local cooling to 33 degrees C will reduce the size of stroke damage in patients who have sufferred an acute stroke but also that the procedure can be peformed safely.
Interventions
Systemic hypothermia is accomplished by an initial rapid infusion of 30ml per kg of ice-cold Hartmann's solution into a 16 guage peripheral intravenous catheter at 100 ml per minute, using a pressure bag. The target temperature of 33 degrees is achieved within about 30 minutes. Hypothermia is maintained by the use of a Therapeutic Goods Association approved endovascular cooling catheter which is inserted into the femoral vein and positioned with the catheter tip in the Inferior Vena Cava below t
Systemic hypothermia is accomplished by an initial rapid infusion of 30ml per kg of ice-cold Hartmann's solution into a 16 guage peripheral intravenous catheter at 100 ml per minute, using a pressure bag. The target temperature of 33 degrees is achieved within about 30 minutes. Hypothermia is maintained by the use of a Therapeutic Goods Association approved endovascular cooling catheter which is inserted into the femoral vein and positioned with the catheter tip in the Inferior Vena Cava below the diaphragm. The endovascular cooling catheters use a heat exchange element within which circulates chilled sterile 0.9% saline within a closed internal circulatory system. The patient's rectal core temperature is monitored and provides a feedback system to the cooling system to maintain target temperature and control rewarming. the patient is cooled at 33 degrees for 24 hours and is rewarmed slowly to 37 degrees over 12 hours.
Sponsors
AUSTRALIAN BRAIN FOUNDATION
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinico-radiological assessment consistent with acute hemispheric ischaemic stroke; presentation within 6 hours of the onset of symptoms or within 6 hours of when last seen unaffected; Perfusion cerebral CT scan demonstrating evidence of hypoperfused but still viable hemispheric brain tissue comprising at least 100% of the hypoperfused “region at risk”; National Institutes of Health Stroke Scale (NIHSS) >= 8; Written informed consent from patient, or if appropriate and approval granted, from Person Responsible.
Exclusion criteria
Rapidly improving neurological deficit or deficit that has resolved to NIHSS <8 at time of randomisation; Very severe acute stroke syndrome with Middle Cerebral Artery (MCA) plus Anterior Communicating Artery/Posterior Communicating Artery (ACA/PCA) or any acute MCA syndrome where, at the time of assessment, the site chief investigator considers hemicraniectomy may be required within 36 hours from onset; Any intracranial haemorrhage on baseline imaging; Any known serious co-morbid condition likely to complicate therapy such as a history of cardiac failure requiring pharmacotherapy, chronic liver disease, abdominal or pelvic mass causing femoral or inferior vena caval obstruction, Inferior Vena Cava (IVC) filters; Acute pulmonary oedema, respiratory, renal or hepatic failure as judged by the treating physician; Life expectancy < 3 months due to co-morbid conditions; Pre-morbid modified Rankin scale of >2; Pregnancy (women of child bearing potential will have a urine pregnancy test); Known allergy to pethidine.
Outcome results
None listed