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Clinical Trials/NCT00541827
NCT00541827CompletedNot Applicable

Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 site in 1 country50 target enrollmentStarted: October 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Mitochondrial respiratory chain enzyme activity

Study Overview

Brief Summary

The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients. Secondary aims are to clarify the pathogenesis and the clinical relevance of mitochondrial damage during sepsis.

Detailed Description

The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients, as compared to otherwise healthy surgical ones. In order to better clarify the pathogenesis of mitochondrial dysfunction during sepsis, cardiogenic shock patients (suffering from systemic hypoperfusion) will act as additional controls. Markers of oxidative stress will be measured in tissue samples from septic patients. The clinical relevance of mitochondrial dysfunction during sepsis will be assessed in terms of both skeletal muscle and platelet function.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Consecutive ICU-admitted severely septic or septic shock patients.

Exclusion Criteria

  • Severe thrombocytopenia.
  • Severe coagulopathy.
  • Pre-existing mitochondrial disease

Outcomes

Primary Outcomes

Mitochondrial respiratory chain enzyme activity

Time Frame: On day one and seven from admission to ICU

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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