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Open Access Highly Accessed Study protocol

Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article)

Geetha Kayambu1*, Robert J Boots12 and Jennifer D Paratz1

Author Affiliations

1 Burns, Trauma & Critical Care Research Centre, School of Medicine, The University of Queensland, Brisbane QLD 4029, Australia

2 Department of Intensive Care Medicine, The Royal Brisbane and Women's Hospital, Brisbane QLD 4029, Australia

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BMC Anesthesiology 2011, 11:21  doi:10.1186/1471-2253-11-21

Published: 31 October 2011

Abstract

Background

Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU) patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU.

Methods/Design

A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252) will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care.

The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test). Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow.

Discussion

The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness.

Trial Registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000808044