A multi-centre phase 2b randomised controlled trial investigating the efficacy and safety of intravenous paracetamol in reducing core body temperature after traumatic brain injury

South Eastern Sydney and Illawarra Area Health Service0 个研究点目标入组 44 人开始时间: 2009年6月12日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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

发起方

South Eastern Sydney and Illawarra Area Health Service