NCT00583206

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

December 20, 2007

Last Update Submit

February 24, 2017

Conditions

AtrophySepsisWeakness

Keywords

sepsisatrophymuscleweakness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis

    7 days

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe sepsis

You may qualify if:

  • Severe sepsis for \< 72hr

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscle RNA; blood

MeSH Terms

Conditions

AtrophySepsisAsthenia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesSigns and Symptoms
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

US(1)