The Paracetamol After traumatic Brain Injury Study
- Conditions
- Traumatic brain injuryInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12609000444280
- Lead Sponsor
- South Eastern Sydney and Illawarra Area Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
Written informed consent has been obtained from the patient’s next of kin
Age > 18 and < 65
Non penetrating head injury requiring mechanical ventilation, and, with an abnormal CT head (defined by the presence of haemorrhage, contusion, swelling, compression of basal cisterns or herniation)
Within 72 hours of injury
Presence (or imminent placement) of arterial cannula
Alanine transferase level < 100
Suspected paracetamol overdose
Clinician decision to institute any intervention that modifies body temperature
Body temperature at time of recruitment less that 36 degrees celsius or greater than 38.9 degrees celcius
Treatment with paracetamol, non-steroidal anti-inflammatory drugs or steroids in 3 days prior to admission
History of chronic liver disease or chronic alcohol abuse
Suspected malnutrition or weight < 60 kg
Renal failure with serum creatinine > 200
Haemodynamic instability defined as systolic blood pressure < 90 mmhg or requirement for noradrenaline or adrenaline exceeding 20mcg/minute
Minor head injury: either normal CT head or not expected to be in intensive care for 72 hours
Suspected pregnancy
GCS<3 with fixed dilated pupils
Moribund patient expected to die within 24 hours
Allergy to paracetamol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bladder Temperature using temperature sensing indwelling catheters[Mean bladder temperature from the start of study treatment until 4 hours after completion of study treatment period (this is a 76 hour study period).]
- Secondary Outcome Measures
Name Time Method Blood Pressure (systolic and mean arterial pressure) measured by intra-arterial pressure monitor[6 hourly during study treatment];Liver function test[daily from first dose of study treatment to the 7th day];serum Paracetamol levels (blood analysis) after a single dose of study drug and after final dose of study drug.[baseline, 30, 45, 90, 240 minutes after single dose. 240 minutes after final dose of study drug];The use of Physical Cooling: defined as whether a physical cooling device (e.g. ice packs, cooling blanket or intravenous cooling catheter) was used - collected hourly (Yes/No)[Hourly from fisrt study drug treatment until 4 hours after final study drug treatment]