Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

This study has been completed.
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT00541827
First received: October 8, 2007
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition
Severe Sepsis
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • Mitochondrial respiratory chain enzyme activity [ Time Frame: On day one and seven from admission to ICU ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

muscle tissue, platelets, plasma


Enrollment: 50
Study Start Date: October 2007
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult ICU-admitted severely septic and septic shock patientes; adult ICU-admitted cardiogenic shock patients; surgical patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe thrombocytopenia.
  • Severe coagulopathy.
  • Pre-existing mitochondrial disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541827

Locations
Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
European Society of Intensive Care Medicine
Investigators
Study Chair: Luciano Gattinoni, MD Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Principal Investigator: Alessandro Protti, MD Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
  More Information

No publications provided

Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT00541827     History of Changes
Other Study ID Numbers: assente
Study First Received: October 8, 2007
Last Updated: September 26, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Sepsis. Shock, septic. Mitochondria.

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on September 30, 2014