Ignite Creation Date:
2024-05-06 @ 8:05 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02666703
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2016-01-17
Brief Title:
Extracorporeal Cytokine Adsorption in Cardiac Surgery
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
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:
IMEECCACS
Brief Summary:
The modern era of cardiac surgery began in early 1950s with the introduction of cardiopulmonary bypass CPB Although it has been clearly shown that CPB is almost unavoidable for most open heart operations an undesirable systemic inflammatory response syndrome SIRS is associated with its use This complex chain of events has strong similarities with sepsis and may contribute to the development of postoperative complications and multiple organ failure MOF It has been shown that an excessive compensatory anti-inflammatory response CARS after SIRS can lead to immune paralysis and increased rate of hospital acquired infection The balance of pro-inflammatory and anti-inflammatory mediators determines the inflammatory response and the clinical outcome Accordingly great efforts have been focused on therapeutic interventions aimed at reducing the inflammatory reactions during CPB including pharmacologic strategies and modification of surgical techniques or mechanical devices Such therapies may provide improvements in patient outcome after open heart operations Among pharmacologic strategies is the prophylaxis with corticosteroids which have been used during open heart surgery for more than 30 years Many studies both experimental and clinical failed to produce evidence in favor of steroid treatment As far as medical devices are concerned the use of extracorporeal cytokine filter CytoSorb looks promising in cardiac surgery It was recently approved by European Medicines Agency as an active treatment to fight cytokine storm
Serum paraoxonase 1 PON1 is a lipo-lactonase being associated with HDL that has an anti-inflammatory role and protects against atherosclerosis Low levels of PON1 are associated with venous graft occlusion in patients with coronary artery bypass grafting PON1 reduces monocyte chemotaxis and adhesion to endothelial cells leading to inhibition of the differentiation of monocytes into macrophages The effects of cytokine adsorption therapy on PON1 are unknown
The aim of the study is to explore the effects of extracorporeal immunoadsorption during CPB on pro-inflammatory and anti-inflammatory protective mediators and cellular immune status in cardiac surgery
Serum paraoxonase 1 PON1 is a lipo-lactonase being associated with HDL that has an anti-inflammatory role and protects against atherosclerosis Low levels of PON1 are associated with venous graft occlusion in patients with coronary artery bypass grafting PON1 reduces monocyte chemotaxis and adhesion to endothelial cells leading to inhibition of the differentiation of monocytes into macrophages The effects of cytokine adsorption therapy on PON1 are unknown
The aim of the study is to explore the effects of extracorporeal immunoadsorption during CPB on pro-inflammatory and anti-inflammatory protective mediators and cellular immune status in cardiac surgery
Detailed Description:
Patients undergoing complex cardiac surgery with CPB eg combined valve and coronary bypass grafting surgery concomitant valve surgery surgery of the ascending aorta and aortic arch as well as re-operations of the same type will be enrolled in the study after giving the signed informed consent They will be randomized into 3 groups 1 study CytoSorb group 2 control group and 3 corticosteroid group Immune response TNF-alfa tumor necrosis factor-alpha ILinterleukin-1 IL-6 IL-8 IL-10 complement C5a lymphocyte cellular markers CD64 CD163 miRNA micro RNA PON1 activity as well as lipid status hs-CRP high sensitivity C-reactive protein PCT procalcitonin and acute phase proteins will be determined before CPB during CPB immediately after 24h 48h and 5 days after CPB We will document demographic characteristics of patients their preoperative medical status as well as intraoperative data type and duration of surgery duration of CPB period of ischemia hemodynamic parameters usage of inotropicvasoactive therapy insulin fluids blood and blood components duration of mechanical ventilation in intensive care unit ICU duration of ICU stay 30-day mortality and morbidity as well as postoperative complications bleeding hemodynamic instability impaired respiratory function infection worsening of renal liver and cognitive function
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