Muscle Atrophy in Sepsis - Full Text View

Purpose

Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical stimulation will reduce the impact of sepsis.

Condition

Atrophy
Sepsis
Weakness

MedlinePlus related topics:

Sepsis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Biochemical Pathways to Skeletal Muscle Atrophy in Human Sepsis

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes within skeletal muscle of patients with sepsis [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Muscle RNA; blood

Estimated Enrollment:	25
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Hypothesis 1: Severe sepsis will be associated with downregulation of anabolic signaling molecules and genes, upregulation of catabolic signaling molecules and genes, and the development of histologic and electrophysiologic abnormalities within skeletal muscle.

Hypothesis 2: Electrical stimulation will improve muscle strength in patients with sepsis.

Hypothesis 3: Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes, and improvement of histologic and electrophysiologic parameters within skeletal muscle of patients with sepsis.

Hypothesis 4: The ratio of catabolic:anabolic gene expression on Day 3 will be positively correlated with the severity of clinical weakness on Day 7

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Severe sepsis

Criteria

Inclusion Criteria:

Severe sepsis for < 72hr

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583206

Contacts


Contact: Gregory A Schmidt, MD	3193846746	gregory-a-schmidt@uiowa.edu

Locations


United States, Iowa
	University of Iowa Hospitals	Recruiting
	Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

More Information

Responsible Party:	University of Iowa ( Gregory A. Schmidt )
Study ID Numbers:	200706755
First Received:	December 20, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00583206
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

sepsis

atrophy

muscle

weakness

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Pathological Conditions, Anatomical

Signs and Symptoms

Sepsis

Asthenia

Neurologic Manifestations

Atrophy

Muscular Atrophy

Inflammation

Additional relevant MeSH terms:

Neuromuscular Manifestations

Pathologic Processes

Nervous System Diseases

Infection

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00583206