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NCT00583206 Clinical Trial

Muscle Atrophy in Sepsis

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00583206
Other study ID # 200706755
Secondary ID
Status Withdrawn
Phase N/A
First received December 20, 2007
Last updated February 24, 2017
Start date December 2007
Est. completion date December 2009

Study information
Verified date February 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Severe sepsis for < 72hr

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Iowa Hospitals Iowa City Iowa

Sponsors (1)
Lead Sponsor Collaborator
Gregory A. Schmidt

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 days
Secondary Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis 7 days
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