Exercise in Critically Ill Patients With Sepsis

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis Syndromes
• Intervention / Treatment: Other: Usual practice; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane & Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Royal Brisbane and Women's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): June 3, 2011
• Last Update Submitted That Met QC Criteria: June 2, 2011
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Bacteremia; Septic shock; Sepsis; Severe sepsis; Septicaemia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Shock; Sepsis; Toxemia; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: XSEP1