Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients
NCT ID: NCT02589535
Last Updated: 2017-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
66 participants
OBSERVATIONAL
2015-12-31
2018-06-30
Brief Summary
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The 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.
Secondary 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).
Detailed Description
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Secondary objective 1: to investigate the relationship between these factors: CD133/CD34, HIF-1 and SDF-1a.
Secondary 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).
In 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.
Each 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:
* C group: postoperative non septic patients in emergency surgical ward (ES) (control group)
* 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
The 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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septic
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
No interventions assigned to this group
no septic
Ga: postoperative patients in emergency surgical ward (ES)
No interventions assigned to this group
healthy
Healthy people
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Fondo di Sviluppo e Coesione 2007-2013 APQ RicercaRegionePuglia FutureInResearch
UNKNOWN
University of Foggia
OTHER
Responsible Party
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Cotoia Antonella
Aggregate Professor, PhD
Principal Investigators
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Antonella Cotoia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Ludwigshafen
Locations
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University of Foggia
Foggia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Antonella Cotoia, MD, PhD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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69/CE/2015
Identifier Type: -
Identifier Source: org_study_id