Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426192
Status:
UNKNOWN
Last Update Posted:
2007-01-24
First Post:
2007-01-03
Brief Title:
Effects of Hemofiltration and Mannitol Treatment on Cardiopulmonary-Bypass Induced Immunosuppression
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
Mechanisms of Endotoxin-Tolerance of Human Monocytes After CABG-Sugery - Effects of Hemofiltration and Mannitol Treatment
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_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:
After cardiac surgery with cardiopulmonar bypass the LPS-stimulated cytokine response has been previously shown to be depressed Therefore in this trial the hypothesis was tested whether simple immunomodulting interventions like the iv adminstration of mannitol of hemofiltration during cardipulmonary bypass can attenuate this immunosuppressing effect
Detailed Description:
Background Cardiac surgery using cardiopulmonary bypass CPB causes a systemic inflammatory response In addition to this immune response to CPB a significant impairment of the responsiveness of peripheral blood mononuclear cells PBMC to further immunological stimuli has been observed The aim of our present study was to evaluate the ability of antioxidant therapy with mannitol or hemofiltration during CPB to modulate the observed immunosuppression after CPB
Methods With ethics committee approval 52 patients undergoing elective CABG-surgery were prospectively enrolled and randomized into 3 groups control 50 g mannitol iv hemofiltration during CPB Blood samples were taken after induction of anesthesia T1 20 min after separation from CPB T2 and 24 h postoperatively T3 Expression density of the monocytic surface receptor CD14 HLA-DR expression and cytokine release TNF- and IL10 after LPS-stimulation were evaluated
Results At T2 the CD14dim cell population was maintained in both intervention groups while in the control group there was a significant decrease of this proinflammatory monocytic phenotype At T3 all groups developed a significant shift towards the antiinflammatory CD14bright population No significant differences regarding HLA-DR expression or cytokine release could be demonstrated
Conclusion This study shows that the suppression of the stimulated immune response after CPB can be alleviated by iv administration of mannitol or hemofiltration In the light of data showing that this depression of the immune response might affect the postoperative course of patients these results could lead to an improvement of the management of patients undergoing cardiac surgery with CPB
Methods With ethics committee approval 52 patients undergoing elective CABG-surgery were prospectively enrolled and randomized into 3 groups control 50 g mannitol iv hemofiltration during CPB Blood samples were taken after induction of anesthesia T1 20 min after separation from CPB T2 and 24 h postoperatively T3 Expression density of the monocytic surface receptor CD14 HLA-DR expression and cytokine release TNF- and IL10 after LPS-stimulation were evaluated
Results At T2 the CD14dim cell population was maintained in both intervention groups while in the control group there was a significant decrease of this proinflammatory monocytic phenotype At T3 all groups developed a significant shift towards the antiinflammatory CD14bright population No significant differences regarding HLA-DR expression or cytokine release could be demonstrated
Conclusion This study shows that the suppression of the stimulated immune response after CPB can be alleviated by iv administration of mannitol or hemofiltration In the light of data showing that this depression of the immune response might affect the postoperative course of patients these results could lead to an improvement of the management of patients undergoing cardiac surgery with CPB
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