Muscle Atrophy in Sepsis | NCT00583206

Studies
Muscle Atrophy in Sepsis

NCT00583206

Sponsor

Gregory A. Schmidt

Status

Withdrawn

Last Update Posted

Feb 28, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Atrophy
Sepsis
Weakness

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2017

Last Update Posted Date

Feb 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis		7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe sepsis for < 72hr

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Severe sepsis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Hospitals		Iowa City	Iowa	52242	United States

Condition Browse Module

MeSH Terms

ID	Term
D001284	Atrophy
D018805	Sepsis
D001247	Asthenia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided