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Exercise in Critically Ill Patients With Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by The University of Queensland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Royal Brisbane and Women's Hospital
Information provided by:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT01364909
First received: May 27, 2011
Last updated: June 2, 2011
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention
Sepsis Syndromes
 Other: Exercise
Other: Usual practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Queensland:

Primary Outcome Measures:
  • Fat free mass ie muscle mass (lean tissue) [ Time Frame: Change from baseline to one week, then change from baseline to two weeks ] [ Designated as safety issue: No ]
    Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia).


Secondary Outcome Measures:
  • Interleukin 6 [ Time Frame: Change from baseline to measurements taken daily for 7 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change from baseline to measurements taken daily for 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline to measurements taken daily for 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Fifteen minutes pre and post every exercise session recorded every 10 seconds ] [ Designated as safety issue: Yes ]
    Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips)


Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control (usual practice) Other: Usual practice
These patients will not receive exercise early in their intensive care admission
Experimental: Exercise Other: Exercise

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364909

Locations
Australia, Queensland
Royal Brisbane & Womens Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
The University of Queensland
Royal Brisbane and Women's Hospital
  More Information

No publications provided

Responsible Party: Dr Jennifer Paratz, The University of Queensland
ClinicalTrials.gov Identifier: NCT01364909     History of Changes
Other Study ID Numbers: XSEP1
Study First Received: May 27, 2011
Last Updated: June 2, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of Queensland:
Sepsis
Severe sepsis
Septic shock
Septicaemia
Bacteremia

Additional relevant MeSH terms:
Critical Illness
Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Disease Attributes
 Pathologic Processes
Infection
Inflammation
Shock

ClinicalTrials.gov processed this record on May 16, 2013