Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02589535
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2015-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients
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_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-03', 'studyFirstSubmitDate': '2015-10-24', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time course level of circulating endothelial progenitor stem cells CD133+/CD34+, HIF1 and SDF in septic patients undergoing emergency major abdominal surgery.', 'timeFrame': '1-10 days after intervention', 'description': 'to determine the time course level of the circulating EPC (CD133/CD34), SDF-1a, and HIF-1 in septic patients undergoing major abdominal surgery.'}], 'secondaryOutcomes': [{'measure': 'correlation among time course level of circulating stem cells, hypoxia-inducible factor-1 (HIF-1) and stromal derived factor - 1 (SDF-1)', 'timeFrame': '1-10 days after intervention', 'description': 'to investigate the relationship between these factors: CD133/CD34, HIF-1 and SDF-1a.'}, {'measure': 'relationship between CD133/CD34, HIF-1, SDF-1a and outcome.', 'timeFrame': '1-10 days after intervention', 'description': 'to investigate the relationship between CD133/CD34, HIF-1, SDF-1a and outcome of patients treated with conventional therapy alone or plus extracorporeal hemoperfusion therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '16439688', 'type': 'RESULT', 'citation': 'Friedrich EB, Walenta K, Scharlau J, Nickenig G, Werner N. CD34-/CD133+/VEGFR-2+ endothelial progenitor cell subpopulation with potent vasoregenerative capacities. Circ Res. 2006 Feb 17;98(3):e20-5. doi: 10.1161/01.RES.0000205765.28940.93. Epub 2006 Jan 26.'}, {'pmid': '18467899', 'type': 'RESULT', 'citation': 'Cribbs SK, Martin GS, Rojas M. Monitoring of endothelial dysfunction in critically ill patients: the role of endothelial progenitor cells. Curr Opin Crit Care. 2008 Jun;14(3):354-60. doi: 10.1097/MCC.0b013e3282fc216d.'}, {'pmid': '23979379', 'type': 'RESULT', 'citation': 'Kalil AC, Florescu MC. Blood purification: can we purify our patients from sepsis? Crit Care Med. 2013 Sep;41(9):2244-5. doi: 10.1097/CCM.0b013e318291cad5. No abstract available.'}, {'pmid': '32593288', 'type': 'DERIVED', 'citation': 'Cotoia A, Cela O, Palumbo G, Altamura S, Marchese F, Mangialetto N, La Bella D, Lizzi V, Capitanio N, Cinnella G. High mobilization of CD133+/CD34+ cells expressing HIF-1alpha and SDF-1alpha in septic abdominal surgical patients. BMC Anesthesiol. 2020 Jun 27;20(1):158. doi: 10.1186/s12871-020-01068-w.'}, {'pmid': '29530072', 'type': 'DERIVED', 'citation': 'Cotoia A, Mirabella L, Altamura S, Villani R, Marchese F, Ferrara G, Mariano K, Livio T, Cinnella G. Circulating stem cells, HIF-1, and SDF-1 in septic abdominal surgical patients: randomized controlled study protocol. Trials. 2018 Mar 12;19(1):179. doi: 10.1186/s13063-018-2556-0.'}]}, 'descriptionModule': {'briefSummary': 'Septic shock is a systemic inflammatory response syndrome with acute circulatory failure secondary to a documented infection. It is the most feared complication in ICU patients, with a 50% mortality rate.\n\nThe study of stem cells and their experimental use in sepsis treatment is particularly relevant in the international scientific research, where Italy plays an important role. In the vast and complex field of stem cell research, the primary aim of the current proposal is to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + / CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1) and stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery.\n\nSecondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1a and outcome of septic/septic shock patients treated with standard conventional therapy alone (CT) or with extracorporeal hemoperfusion therapy (HCT).', 'detailedDescription': 'Primary objective: to determine the time course level of the circulating EPC (CD133/CD34), SDF-1a, and HIF-1 in septic patients undergoing major abdominal surgery.\n\nSecondary objective 1: to investigate the relationship between these factors: CD133/CD34, HIF-1 and SDF-1a.\n\nSecondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1° and outcomeof septic/septic shock patients treated with standard conventional therapy alone (CT) or with extracorporeal hemoperfusion therapy (HCT).\n\nIn this trial, we hypothesize that CD133/CD34, HIF1 and SDF1a will increase in septic surgical patients as consequence of impaired tissue perfusion and cellular hypoxia. Our hypothesis is based on the fact that the stimulation of factors hypoxia-related, as SDF-1a and HIF-1 could be the primary step for bone marrow stem cells stimulation. Furthermore, we assume that survivors septic patients will show higher levels of EPC, HIF-1 and SDF-1a.\n\nEach day, the anesthesiologist of the operating room and the on-call anesthesiologist will alerts the principal investigator to a potential eligible patient. Participants included in the trial will be divided into two groups:\n\n* C group: postoperative non septic patients in emergency surgical ward (ES) (control group)\n* S group: postoperative septic shock patients in intensive care unit (ICU) Healthy volunteers (H group) will be recruited from among staff members of the University Hospital of Foggia\n\nThe research study can provide useful parameters for early diagnostic and therapeutic interventions in sepsis which is the leading cause of death from infection, with an incidence of approximately 10% in ICU postoperative patients according to recent epidemiologic studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'postoperative patients undergoing major abdominal surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nCaucasian, Over 18 years of age\n\nExclusion criteria:\n\nwhen it is impossible to collect blood samples (organizational reasons or because of emergencies regarding the health of the patients),Pregnant patients,Organ transplantation, Palliative care,Metastatic cancer patients'}, 'identificationModule': {'nctId': 'NCT02589535', 'briefTitle': "Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients", 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Circulating Stem Cells, SDF-1, HIF-1 and Sepsis: Relationship Between Indices of Sepsis and Emergency Abdominal Surgical Patients', 'orgStudyIdInfo': {'id': '69/CE/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'septic', 'description': 'Group Gb: postoperative septic patients in intensive care unit (ICU)\\] Gb1: the group of septic patients treated with extracorporeal hemoperfusion therapy and conventional therapy according to the Surviving Sepsis Campaign guidelines Gb2 group treated with conventional therapy according to the Surviving Sepsis Campaign guidelines'}, {'label': 'no septic', 'description': 'Ga: postoperative patients in emergency surgical ward (ES)'}, {'label': 'healthy', 'description': 'Healthy people'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71122', 'city': 'Foggia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Cotoia, MD, PhD', 'role': 'CONTACT', 'email': 'antonella.cotoia@unifg.it', 'phone': '390881732387'}], 'facility': 'University of Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}], 'centralContacts': [{'name': 'Antonella Cotoia, MD, PhD', 'role': 'CONTACT', 'email': 'antonella.cotoia@unifg.it', 'phone': '+390881732387'}, {'name': 'Gilda Cinnella, Prof, MD', 'role': 'CONTACT', 'email': 'gilda.cinnella@unifg.it', 'phone': '+390881732387'}], 'overallOfficials': [{'name': 'Antonella Cotoia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Ludwigshafen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondo di Sviluppo e Coesione 2007-2013 APQ RicercaRegionePuglia FutureInResearch', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Aggregate Professor, PhD', 'investigatorFullName': 'Cotoia Antonella', 'investigatorAffiliation': 'University of Foggia'}}}}