Ignite Creation Date:
2024-05-06 @ 7:41 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02589535
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2015-10-24
Brief Title:
Circulating Stem Cells SDF-1 HIF-1 and Sepsiss Indices in Emergency Abdominal Surgical Patients
Sponsor:
University of Foggia
Organization:
University of Foggia
Study Overview
Official Title:
Circulating Stem Cells SDF-1 HIF-1 and Sepsis Relationship Between Indices of Sepsis and Emergency Abdominal Surgical Patients
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 CD133CD34 HIF-1 SDF-1a and outcome of septicseptic shock patients treated with standard conventional therapy alone CT or with extracorporeal hemoperfusion therapy HCT
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 CD133CD34 HIF-1 SDF-1a and outcome of septicseptic shock patients treated with standard conventional therapy alone CT or with extracorporeal hemoperfusion therapy HCT
Detailed Description:
Primary objective to determine the time course level of the circulating EPC CD133CD34 SDF-1a and HIF-1 in septic patients undergoing major abdominal surgery
Secondary objective 1 to investigate the relationship between these factors CD133CD34 HIF-1 and SDF-1a
Secondary objective 2 to investigate the relationship between CD133CD34 HIF-1 SDF-1 and outcomeof septicseptic shock patients treated with standard conventional therapy alone CT or with extracorporeal hemoperfusion therapy HCT
In this trial we hypothesize that CD133CD34 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
Secondary objective 1 to investigate the relationship between these factors CD133CD34 HIF-1 and SDF-1a
Secondary objective 2 to investigate the relationship between CD133CD34 HIF-1 SDF-1 and outcomeof septicseptic shock patients treated with standard conventional therapy alone CT or with extracorporeal hemoperfusion therapy HCT
In this trial we hypothesize that CD133CD34 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None