Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-15 @ 1:22 PM
Study NCT ID:
NCT00541827
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2007-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'muscle tissue, platelets, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-26', 'studyFirstSubmitDate': '2007-10-08', 'studyFirstSubmitQcDate': '2007-10-09', 'lastUpdatePostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial respiratory chain enzyme activity', 'timeFrame': 'On day one and seven from admission to ICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sepsis. Shock, septic. Mitochondria.'], 'conditions': ['Severe Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '25757508', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU-admitted severely septic and septic shock patientes; adult ICU-admitted cardiogenic shock patients; surgical patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive ICU-admitted severely septic or septic shock patients.\n\nExclusion Criteria:\n\n* Severe thrombocytopenia.\n* Severe coagulopathy.\n* Pre-existing mitochondrial disease'}, 'identificationModule': {'nctId': 'NCT00541827', 'briefTitle': 'Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis', 'orgStudyIdInfo': {'id': 'assente'}}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Luciano Gattinoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ospedale Maggiore Policlinico Mangiagalli e Regina Elena'}, {'name': 'Alessandro Protti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Maggiore Policlinico Mangiagalli e Regina Elena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society of Intensive Care Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}