Sepsis Syndromes
Conditions
Keywords
Sepsis, Severe sepsis, Septic shock, Septicaemia, Bacteremia
Brief summary
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.
Detailed description
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.
Interventions
OTHERExercise
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
OTHERUsual practice
These patients will not receive exercise early in their intensive care admission
Sponsors
Royal Brisbane and Women's Hospital
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat free mass ie muscle mass (lean tissue) | Change from baseline to one week, then change from baseline to two weeks | Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 6 | Change from baseline to measurements taken daily for 7 days | 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. |
| Tumour necrosis factor alpha (TNF-alpha) | Change from baseline to measurements taken daily for 7 days | 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. |
| Interleukin 10 | Change from baseline to measurements taken daily for 7 days | 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. |
| Vital signs - observation only | Fifteen minutes pre and post every exercise session recorded every 10 seconds | Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips) |
Countries
Australia
Outcome results
None listed