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OpenTrials
Completed

NCT Number: NCT00541827

Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milan, Italy, 20122

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Mitochondrial respiratory chain enzyme activity

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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • European Society of Intensive Care Medicine

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Oct 10, 2007
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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