Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Recruitment status was: Not yet recruiting
Heart Valve Diseases
Systemic Inflammatory Response Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response|
- recovery of monocyte subsets [ Time Frame: baseline, day1, 3, 5, 7 postoperative ] [ Designated as safety issue: No ]Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Methylprednisolone will be given during cardiopulmonary bypass.
500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
Other Name: Solu-Medrol
Systemic inflammatory response syndrome (SIRS) is a common major complication of cardiopulmonary bypass. "Emergency Hematopoiesis" is the pathological process induced by the inflammation. The investigators previously confirmed that emergency hematopoiesis induced by cardiopulmonary bypass led to dynamic changes of quantities of monocyte subsets, there is a significant increase in the number of two monocyte subsets: 1) CD14highCD16+ monocyte with strong immunomodulatory activity; 2) CD14lowCD16- monocyte with potential ability of proliferation and differentiation. Therefore, a new hypothesis risen: "the change of the function and the number of monocyte subsets induced by emergency hematopoiesis play an important role for SIRS occurrence after cardiopulmonary bypass, correcting emergency hematopoiesis is a new breakthrough in the prevention and treatment of SIRS." To identify the mechanism of function changed in different monocyte subsets during the pathogenesis of SIRS, the research intended to target perioperative-period patients with heart valve replacement, monitor dynamically the number and phenotype of peripheral blood monocyte subsets by flow cytometry; sort out of different monocyte subsets for cell culture in vitro, observe the ability of proliferation and differentiation and effects between monocyte subsets and T lymphocyte; investigate the mechanism of immune function changes with antibody-blocking and compartment culture in patients; observe the impact of glucocorticoid treatment on the emergency hematopoiesis, offer new objects for evaluation of immune status in patients and provide new evidence for anti-inflammatory therapy .
Patients should be follow the protocol of cardiopulmonary bypass according to normal hospital routine practice.
A total of 30 patients will be enrolled in this clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296074
|Beijing, Beijing, China, 100029|
|Principal Investigator:||Xiaotong Hou, M.D., Ph.D.||Beijing Anzhen Hospital, Capital Medical University|