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The REACTOR trial

ANZICS CTG Endorsed Study

The REACTOR trial

Randomised evaluation of active control of temperature vs. ordinary temperature management

Study Description

The REACTOR trial is a multi-centre, open label, parallel groups, phase II feasibility trial in invasively mechanically ventilated adults without acute brain pathologies. This trial is principally being conducted to assess the feasibility of a subsequent phase 3 clinical trial.  The proposed phase 3 trial will answer the following PICO question:

Among adults in ICU without acute brain pathologies who are expected to be ventilated beyond the day after randomisation, does systematic control of body temperature using regular IV paracetamol combined with physical cooling to treat fever, compared to standard temperature management, alter day 90 mortality?

The primary aim of this current trial is to establish the feasibility of the temperature control strategy being assessed in the intervention arm by determining whether or not it reduces mean body temperature compared to standard temperature management.

Management Committee

Paul Young (Chair), Michael Bailey, Frances Bass (Project Manager), Richard Beasley, Rinaldo Bellomo, Ross Freebairn, Naomi Hammond, Frank van Haren, Meg Harward (Project Manager on parental leave from 04 July 2017), Seton Henderson, Diane Mackle, Colin McArthur, Shay McGuinness, John Myburgh, Manoj Saxena, Anne Turner (Project Manager) and Steve Webb.

Administering Institution

Medical Research Institute of New Zealand

Collaborators

The George Institute of Global Health

Sample Size

184 patients

Funding

Health Research Council of New Zealand Feasibility Grant NZ$149,799

Project Status as of June 2019

Study recruitment continues slowly with 119 patients enrolled.

The REACTOR trial completed recruitment on 12 March 2019.

The results showed that systematic prevention and treatment of fever reduced mean body temperature by about 0.5°C compared to usual temperature management.

Patients assigned to systematic prevention and treatment of fever received more paracetamol than patients assigned to usual temperature management and had more hours of physical cooling in the ICU.

In patients assigned to usual temperature management, fever often abated within 24 hours of randomisation.

Patients assigned to systematic prevention and treatment of fever had lower heart rate than patients assigned to usual temperature management but other physiological parameters were similar.

In hospital mortality, ICU length of stay, hospital length of stay, ICU-free days, ventilator-free days, vasopressor-free days, and receipt of renal replacement therapy were all similar by treatment group.

These 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 to critically ill patients.

A manuscript is in progress for submission to Intensive Care Medicine.

Reference

CTG1617-003
ACTRN12616001285448
UTN: U1111-1182-7938

Contact

Paul Young (email)