The George Institute For Global Health
Global
United Kingdom
India
China
Australia

Audit of temperature regulation in intensive care patients with traumatic brain injury and stroke in Australia and New Zealand (CLARITY)

Project status: 
Archived
Start date: 
07/2012

Traumatic Brain Injury (TBI) and Stroke (ischaemic and haemorrhagic, including aneurysmal and non-aneurysmal haemorrhage) are globally the most common forms of neurologically-related disability in adults. The incidence of both conditions is projected to increase substantially worldwide. There remains a paucity of high quality data to guide how to manage temperature in these conditions in the acute phase.

In stroke and traumatic brain injury, the evidence for the intervention of maintaining a normal body temperature (“normothermia”) is based largely on experimental and clinical observational studies. Systematic reviews, expert opinions and consensus group opinions support this perspective of clinical uncertainty. There are no prospective randomised controlled trials evaluating the safety and efficacy of maintaining a normal body temperature following intensive care admission for stroke or TBI. Indeed, even defining “normothermia” remains contentious.

In order to understand current practice in Australia and New Zealand, a series of observational studies of temperature management after acute brain injury have been undertaken. Data from a point prevalence study and a multi-centre retrospective cohort study suggest that temperature measurements are commonly recorded as over 37 ̊C, and, that there is potential to increase the use of interventions that may reduce temperature.

Aim

To conduct an audit of temperature management after stroke and TBI in order to:

  • Validate the findings of the point prevalence study and the retrospective study
  • Define baseline characteristics of intensive care patients admitted with acute brain injury
  • To describe current temperature management with a view to determining the feasibility of defining potential control and intervention arms for a subsequent randomised controlled trial.

Design

The CLARITY Study is a multi-centre audit across approximately 20 sites in Australia and New Zealand.  The study will recruit 200 patients with an anticipated recruitment period of six months. To ensure a broad representation of baseline characteristics and current practice a maximum of 30 patients will be recruited at each site.

Patients older than 16 years who are expected to remain in ICU for greater than 24 hours and who have a diagnosis of Traumatic Brain Injury or Haemorrhagic or Ischaemic Stroke (on the basis of CT findings) will be eligible for recruitment into the CLARITY Audit.

The characteristics of data collection will aim to provide the information required to define baseline characteristics of intensive care patients admitted with brain injury and also to describe current temperature management for this group of patients.

Methods

Observational data will be collected from the time of intensive care admission until (and including) day 10 of intensive care admission, or ICU discharge (whichever occurs earlier).

Data collection will consist of baseline admission characteristics including CT reports. Daily data collection will include Glasgow coma scale measurements and temperature (both measurement and interventions). Data on other interventions such as surgery, mechanical ventilation and sedation practice as well as the characteristics of Intensive Care and Hospital discharge will also be collected.

Status

Recruitment ended in December 2012. Data analysis complete with presentations and the publication of results expected from mid-2014.