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Muscle Atrophy in Sepsis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by University of Iowa.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00583206
First received: December 20, 2007
Last updated: July 22, 2008
Last verified: July 2008
  Purpose
Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical stimulation will reduce the impact of sepsis.

Condition
Atrophy
Sepsis
Weakness

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biochemical Pathways to Skeletal Muscle Atrophy in Human Sepsis

Resource links provided by NLM:


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
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Iowa
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  More Information

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

Keywords provided by University of Iowa:
sepsis
atrophy
muscle
weakness

Additional relevant MeSH terms:
Sepsis
Toxemia
Atrophy
Muscular Atrophy
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016