Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
18 Years
N/A
Both
Sepsis Syndromes
Trial Information
Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Fat free mass ie muscle mass (lean tissue)
Outcome Description:
Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia).
Outcome Time Frame:
Change from baseline to one week, then change from baseline to two weeks
Safety Issue:
No
Authority:
Australia: Human Research Ethics Committee
Study ID:
XSEP1
NCT ID:
NCT01364909
Start Date:
June 2007
Completion Date:
December 2011
Related Keywords:
- Sepsis Syndromes
- Sepsis
- Severe sepsis
- Septic shock
- Septicaemia
- Bacteremia
- Critical Illness
- Sepsis
- Toxemia
- Systemic Inflammatory Response Syndrome
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