Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 12:04 PM
Study NCT ID:
NCT02019992
Status:
UNKNOWN
Last Update Posted:
2013-12-24
First Post:
2013-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Plasma Mitochondrial DNA Level in Septic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in plasma mtDNA in septic patients at 7 days', 'timeFrame': '7 days', 'description': 'The change from baseline in plasma mtDNA in septic patients at 7 days will be measured by real-time PCR.'}], 'secondaryOutcomes': [{'measure': 'change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days', 'timeFrame': '7 days', 'description': 'The change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days will be measured by ELISA.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sepsis', 'mitochondrial DNA', 'systemic inflammation', 'outcome'], 'conditions': ['Sepsis', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'To determine the plasma levels of mtDNA in ICU department patients with and without sepsis and evaluate their association with severity, systemic inflammation and outcomes. Plasma from control, septic and severe septic patients will be collected. The level of mtDNA and systemic cytokine will be measured.', 'detailedDescription': 'Clinical protocol:\n\nPatients were enrolled into one of three cohorts: (i) sepsis defined as suspected infection and systemic inflammatory response, (ii) septic shock defined as sepsis plus hypotension, and (iii) control defined as non-infected patients without systemic inflammatory response.\n\nMethods:\n\nPlasma levels of mtDNAs were measured using real-time quantitative polymerase chain reaction. Levels of mtDNAs were compared among each group, and linear regression was used to assess the association between mtDNAs, IL-6, TNF a and IL-1b in patients with sepsis. The correlation between plasma mtDNA and severity, systemic inflammation and outcomes will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sepsis and severe septic patients enrolled in 2014 will be collected.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of sepsis and severe sepsis was according to the following guild-line. "Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012"\n\nExclusion Criteria:\n\n* Patients lost following-up. Patients who refuse to sign the consent form.'}, 'identificationModule': {'nctId': 'NCT02019992', 'briefTitle': 'Investigation of Plasma Mitochondrial DNA Level in Septic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Plasma Levels of Mitochondrial DNA in Patients Presenting to ICU With Sepsis', 'orgStudyIdInfo': {'id': 'CSU-ICU-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sepsis', 'description': 'sepsis defined as suspected infection and systemic inflammatory response'}, {'label': 'severe sepsis', 'description': 'sepsis with organ dysfunction or septic shock defined as sepsis plus hypotension'}, {'label': 'control group', 'description': 'control defined as non-infected patients without systemic inflammatory response.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lemeng zhang, md', 'role': 'CONTACT', 'phone': '8673185064389'}, {'name': 'yuhang ai, md', 'role': 'CONTACT', 'phone': '8673284327974'}, {'name': 'lemeng zhang, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xiangya Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'lemeng zhang, md', 'role': 'CONTACT', 'phone': '8673185064389'}, {'name': 'yuhang ai, ma', 'role': 'CONTACT', 'phone': '8673184327074'}], 'overallOfficials': [{'name': 'lemeng zhang, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'md', 'investigatorFullName': 'lemeng zhang', 'investigatorAffiliation': 'Central South University'}}}}