Exercise in Critically Ill Patients With Sepsis

Sepsis Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01364909
• Other study ID #: XSEP1
• Status: Active, not recruiting
• Phase: N/A
• First received: May 27, 2011
• Last updated: June 2, 2011
• Start date: June 2007
• Est. completion date: December 2011

Study information

• Verified date: October 2008
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Sepsis Syndromes
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

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
• Usual practice
These patients will not receive exercise early in their intensive care admission

Locations

Country	Name	City	State
Australia	Royal Brisbane & Womens Hospital	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes