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

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.

Figure 1

Impact of delayed ICU rehabilitation in early sepsis. This diagram illustrates the sequential impact of delayed rehabilitation for patients with sepsis as a result of the inflammatory processes and the detrimental short and long-term outcomes.

Figure 2

Research methodology sequence diagram. The inclusion criteria are as follows: Age ≥ 18 yrs and remain ventilated for ≥ 48 hours; present with documented sepsis or high clinical suspicion of sepsis. Patients with head injuries, burns, spinal injuries, and multiple fractured lower limbs, those with septic shock unresponsive to treatment, moribund or with expected mortality within 48 hours will be excluded.