Exercise in Critically Ill Patients With Sepsis

The University of Queensland40 enrolled

Overview

This study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.

This study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care. The Primary Hypothesis is that an early targeted rehabilitation ICU patients with sepsis syndromes over 7 days will Prevent loss of lean muscle mass by within 7 days of recruitment to the study. Decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sepsis Syndromes

Interventions

ExerciseOTHER

The subjects will be given 2 x 30 minute sessions of exercise per day consisting of either passive, active, active assisted depending on level of sedation and stability of condition. According to level of sedation and stability they may also perform sitting exercises

Usual practiceOTHER

These patients will not receive exercise early in their intensive care admission

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Systemic inflammatory response syndrome with a proven or suspected infectious etiology. * 18 years and over * Relatives willing to give consent * Admitted to intensive care and likely to remain ventilated for \> 48 hours Exclusion Criteria: * Patients with septic shock unresponsive to maximal treatment or who are moribund or have an expected mortality within 48 hours * Head injuries * Burn injury * Multiple lower limb fractures

Locations (1)

Royal Brisbane & Womens Hospital

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

Fat free mass ie muscle mass (lean tissue)

Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia).

Time frame: Change from baseline to one week, then change from baseline to two weeks

Secondary Outcomes

Interleukin 6

5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay.

Time frame: Change from baseline to measurements taken daily for 7 days

Tumour necrosis factor alpha (TNF-alpha)

Time frame: Change from baseline to measurements taken daily for 7 days

Interleukin 10

Time frame: Change from baseline to measurements taken daily for 7 days

Vital signs - observation only

Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips)

Time frame: Fifteen minutes pre and post every exercise session recorded every 10 seconds

Data from ClinicalTrials.gov

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