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CompletedNCT00541827Updated Sep 27, 2013

Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

An observational study in Severe Sepsis and Septic Shock, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-27.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Severe Sepsis
  • Septic Shock

Keywords

  • Sepsis. Shock, septic. Mitochondria.
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 50 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Mitochondrial respiratory chain enzyme activity

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

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Study locations

1 site
  • Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
    Milan, 20122, Italy
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References and documents

Publications

  • Protti A, Fortunato F, Artoni A, Lecchi A, Motta G, Mistraletti G, Novembrino C, Comi GP, Gattinoni L. Platelet mitochondrial dysfunction in critically ill patients: comparison between sepsis and cardiogenic shock. Crit Care. 2015 Feb 11;19(1):39. doi: 10.1186/s13054-015-0762-7. PubMed 25757508 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00541827
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
European Society of Intensive Care Medicine
Responsible party
Sponsor
First posted
Oct 10, 2007
Start date
Oct 2007
Primary completion
Aug 2011
Completion
Aug 2012
Last update
Sep 27, 2013

Study contacts

Luciano Gattinoni, MD
study chair · Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Alessandro Protti, MD
principal investigator · Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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