Randomised Evaluation of Active Control of Temperature vs. Ordinary temperature management in mechanically ventilated adults in ICU with fever.

Phase 2

Completed

• Conditions: Fever; Mechanical ventilation; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12616001285448
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Active temperature management reduced body temperature compared with usual care; however, fever abated rapidly, even in patients assigned to usual care, and the magnitude of temperature separation was small. Our findings do not provide strong support for a larger clinical trial using this design in this patient population. However they do provide preliminary data supporting the safety of regular administration of intravenous paracetamol in critically ill patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-13
• Study Completion: 2019-04-12
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Patients requiring invasive mechanical ventilation in the ICU and expected to be receiving mechanical ventilation beyond the day after randomisation.
2. Fever (body temperature 37.8 degrees Celsius or more) in the previous 12 hours.
3. Deeply sedated with no response to voice

Exclusion Criteria

1. Acute brain pathologies (traumatic brain injury, intracerebral haemorrhage, subarachnoid haemorrhage, or ischaemic stroke).
2. Confirmed or suspected hypoxic ischaemic encephalopathy (includes all patients who have had a recent cardiac arrest where there is clinical concern about possible brain damage as a result of the cardiac arrest).
3. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient, or the substitute decision maker are not committed to full active treatment.
4. Patients admitted to the intensive care unit with greater than or equal to 20% total body surface area burns.
5. Life expectancy of less than 90 days due to an underlying medical condition.
6 Fulfilled all other eligibility criteria >24 hours ago but was not enrolled in the study.
7. Previously enrolled in the REACTOR study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The between group difference in mean body temperature using a core temperature monitoring device (eg bladder thermometer, oesophageal temperature probe or blood temperature probe) where possible. If core temperature monitoring is not possible tympanic temperature monitoring will be used in preference to other devices.[Censored at day 28. This outcome will be assessed using ALL temperatures recorded in ICU for clinical purposes (typically temperature is recorded hourly).]