Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01296074|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Valve Diseases Systemic Inflammatory Response Syndrome||Drug: Corticosteroid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response|
|Actual Study Start Date :||March 2011|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||August 2011|
Methylprednisolone will be given during cardiopulmonary bypass.
500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
Other Name: Solu-Medrol
- recovery of monocyte subsets [ Time Frame: baseline, day1, 3, 5, 7 postoperative ]Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296074
|Beijing, Beijing, China, 100029|
|Principal Investigator:||Xiaotong Hou, M.D., Ph.D.||Beijing Anzhen Hospital|