Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01530932
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sepsis', 'tissue oxygenation', 'tissue perfusion', 'immune reaction'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '34972827', 'type': 'DERIVED', 'citation': 'Sturm T, Leiblein J, Clauss C, Erles E, Thiel M. Bedside determination of microcirculatory oxygen delivery and uptake: a prospective observational clinical study for proof of principle. Sci Rep. 2021 Dec 31;11(1):24516. doi: 10.1038/s41598-021-03922-4.'}, {'pmid': '27686326', 'type': 'DERIVED', 'citation': 'Sturm T, Leiblein J, Schneider-Lindner V, Kirschning T, Thiel M. Association of Microcirculation, Macrocirculation, and Severity of Illness in Septic Shock: A Prospective Observational Study to Identify Microcirculatory Targets Potentially Suitable for Guidance of Hemodynamic Therapy. J Intensive Care Med. 2018 Apr;33(4):256-266. doi: 10.1177/0885066616671689. Epub 2016 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'Sepsis remains a common entity in critical care patients with remarkable mortality. Pulmonary and abdominal infections (with subsequent sepsis) are the most common in the ICU. Despite extended research activities, no differences in patient outcome or organ dysfunction were revealed.\n\nSepsis is a complex immune reaction phenomenon based on unbalanced activation and suppression. In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as a potential important step of immune cell activation) is likely changed during systemic and local immune reactions.\n\nThe aim of this study is to perform a detailed assay of immune cell activation, to investigate the levels of pro- and antiinflammatory cytokines and the various expression of miRNA depending on the origin of infection in the two most common sides. This means in ICU patients with early pulmonary or abdominal sepsis as well as in healthy controls. Additionally, clinical parameters of organ function, current infection markers as CRP and procalcitonin, cardiovascular function and heart rate variability will be assessed. Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma adenosine concentration will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sepsis of pulmonary or abdominal origin with admission to the ICU in the first 48 hours of sepsis onset', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sepsis (according to the criteria of the International Sepsis Definition Conference)\n\nExclusion Criteria:\n\n* pregnancy\n* malignancy\n* corticoid therapy\n* organ transplantation\n* renal insufficiency with HD'}, 'identificationModule': {'nctId': 'NCT01530932', 'briefTitle': 'Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin', 'orgStudyIdInfo': {'id': '2011-411M-MA'}}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'University Hospital Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Timo Sturm', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}