Exercise in Critically Ill Patients With Sepsis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial

Conditions
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Sepsis Syndromes

Intervention / Treatment
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* Other: Exercise
* Other: Usual practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control (usual practice)<br> | Other: Usual practice<br>* These patients will not receive exercise early in their intensive care admission<br>|
| Experimental: Exercise<br> | Other: Exercise<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline to one week, then change from baseline to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to measurements taken daily for 7 days | 
| Tumour necrosis factor alpha (TNF-alpha) | 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. | Change from baseline to measurements taken daily for 7 days | 
| Interleukin 10 | 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. | 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) | Fifteen minutes pre and post every exercise session recorded every 10 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Severe sepsis, Septic shock, Septicaemia, Bacteremia