Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients

Study Overview
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Brief Summary
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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. 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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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. 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.

Official Title
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Circulating Stem Cells, SDF-1, HIF-1 and Sepsis: Relationship Between Indices of Sepsis and Emergency Abdominal Surgical Patients

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Caucasian, Over 18 years of age Exclusion criteria: when 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| septic<br>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 septic<br>Ga: postoperative patients in emergency surgical ward (ES) | |
| healthy<br>Healthy people | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time course level of circulating endothelial progenitor stem cells CD133+/CD34+, HIF1 and SDF in septic patients undergoing emergency major abdominal surgery. | to determine the time course level of the circulating EPC (CD133/CD34), SDF-1a, and HIF-1 in septic patients undergoing major abdominal surgery. | 1-10 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation among time course level of circulating stem cells, hypoxia-inducible factor-1 (HIF-1) and stromal derived factor - 1 (SDF-1) | to investigate the relationship between these factors: CD133/CD34, HIF-1 and SDF-1a. | 1-10 days after intervention | 
| relationship between CD133/CD34, HIF-1, SDF-1a and outcome. | 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 | 1-10 days after intervention |