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Exercise in Critically Ill Patients With Sepsis

Primary Purpose

Sepsis Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Exercise
Usual practice
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis Syndromes focused on measuring Sepsis, Severe sepsis, Septic shock, Septicaemia, Bacteremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brisbane & Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control (usual practice)

Exercise

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2011
Last Updated
June 2, 2011
Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01364909
Brief Title
Exercise in Critically Ill Patients With Sepsis
Official Title
Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis Syndromes
Keywords
Sepsis, Severe sepsis, Septic shock, Septicaemia, Bacteremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (usual practice)
Arm Type
Placebo Comparator
Arm Title
Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual practice
Intervention Description
These patients will not receive exercise early in their intensive care admission
Primary Outcome Measure Information:
Title
Fat free mass ie muscle mass (lean tissue)
Description
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 Outcome Measure Information:
Title
Interleukin 6
Description
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
Title
Tumour necrosis factor alpha (TNF-alpha)
Description
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
Title
Interleukin 10
Description
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
Title
Vital signs - observation only
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Brisbane & Womens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia

12. IPD Sharing Statement

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Exercise in Critically Ill Patients With Sepsis

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