Sepsis Clinical Trial
Official title:
Circulating Stem Cells, SDF-1, HIF-1 and Sepsis: Relationship Between Indices of Sepsis and Emergency Abdominal Surgical Patients
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).
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.
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