Skeletal Muscle and Platelet Mitochondrial Dysfunction Du... | NCT00541827

Studies
Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

NCT00541827

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Completed

Last Update Posted

Sep 27, 2013Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Severe Sepsis
Septic Shock

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Oct 8, 2007

First Submission Date that Met QC Criteria

Oct 9, 2007

First Posted Date

Oct 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2013

Last Update Posted Date

Sep 27, 2013Estimated

Name	Class
European Society of Intensive Care Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mitochondrial respiratory chain enzyme activity		On day one and seven from admission to ICU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive ICU-admitted severely septic or septic shock patients.

Exclusion Criteria:

Severe thrombocytopenia.
Severe coagulopathy.
Pre-existing mitochondrial disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciano Gattinoni, MD	Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	Study Chair
Alessandro Protti, MD	Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena		Milan	Italy	20122	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25757508	Derived	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.

ID	Term
D018805	Sepsis
D012772	Shock, Septic

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes