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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02589535
• Other study ID #: 69/CE/2015
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2015
• Last updated: December 3, 2017
• Start date: December 2015
• Est. completion date: June 2018

Study information

• Verified date: December 2017
• Source: University of Foggia
• Contact: Antonella Cotoia, MD, PhD
• Phone: +390881732387
• Email: antonella.cotoia[@]unifg.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Locations

Country	Name	City	State
Italy	University of Foggia	Foggia

Sponsors (2)

Lead Sponsor	Collaborator
University of Foggia	Fondo di Sviluppo e Coesione 2007-2013 APQ RicercaRegionePuglia FutureInResearch

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View 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. Epub 2006 Jan 26. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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