Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

Septic Shock Clinical Trial

Official title:

Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541827
• Other study ID #: assente
• Status: Completed
• Phase: N/A
• First received: October 8, 2007
• Last updated: September 26, 2013
• Start date: October 2007
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Severe thrombocytopenia.

• Severe coagulopathy.

• Pre-existing mitochondrial disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Toxemia

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial respiratory chain enzyme activity		On day one and seven from admission to ICU	No