Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Primary Purpose
Heart Valve Diseases, Systemic Inflammatory Response Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Corticosteroid
Sponsored by
About this trial
This is an interventional prevention trial for Heart Valve Diseases focused on measuring monocyte, cardiopulmonary bypass, cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- Valve replacement under cardiopulmonary bypass
Exclusion Criteria:
- Cardiopulmonary bypass time over 120 minutes
- Hyperlipidemia
- Diabetes mellitus
- Autoimmune diseases
Sites / Locations
- Xiaotong Hou
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Corticosteroid
Arm Description
Methylprednisolone will be given during cardiopulmonary bypass.
Outcomes
Primary Outcome Measures
recovery of monocyte subsets
Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.
Secondary Outcome Measures
Full Information
NCT ID
NCT01296074
First Posted
February 14, 2011
Last Updated
October 17, 2017
Sponsor
Beijing Anzhen Hospital
Collaborators
National Natural Science Foundation of China
1. Study Identification
Unique Protocol Identification Number
NCT01296074
Brief Title
Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Official Title
The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
National Natural Science Foundation of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases, Systemic Inflammatory Response Syndrome
Keywords
monocyte, cardiopulmonary bypass, cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroid
Arm Type
Experimental
Arm Description
Methylprednisolone will be given during cardiopulmonary bypass.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
Solu-Medrol
Intervention Description
500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
Primary Outcome Measure Information:
Title
recovery of monocyte subsets
Description
Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.
Time Frame
baseline, day1, 3, 5, 7 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Valve replacement under cardiopulmonary bypass
Exclusion Criteria:
Cardiopulmonary bypass time over 120 minutes
Hyperlipidemia
Diabetes mellitus
Autoimmune diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaotong Hou, M.D., Ph.D.
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiaotong Hou
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
19332460
Citation
Ho KM, Tan JA. Benefits and risks of corticosteroid prophylaxis in adult cardiac surgery: a dose-response meta-analysis. Circulation. 2009 Apr 14;119(14):1853-66. doi: 10.1161/CIRCULATIONAHA.108.848218. Epub 2009 Mar 30.
Results Reference
background
PubMed Identifier
18664462
Citation
Whitlock RP, Chan S, Devereaux PJ, Sun J, Rubens FD, Thorlund K, Teoh KH. Clinical benefit of steroid use in patients undergoing cardiopulmonary bypass: a meta-analysis of randomized trials. Eur Heart J. 2008 Nov;29(21):2592-600. doi: 10.1093/eurheartj/ehn333. Epub 2008 Jul 28.
Results Reference
background
PubMed Identifier
15519185
Citation
Bourbon A, Vionnet M, Leprince P, Vaissier E, Copeland J, McDonagh P, Debre P, Gandjbakhch I. The effect of methylprednisolone treatment on the cardiopulmonary bypass-induced systemic inflammatory response. Eur J Cardiothorac Surg. 2004 Nov;26(5):932-8. doi: 10.1016/j.ejcts.2004.07.044.
Results Reference
background
PubMed Identifier
30624149
Citation
Hao X, Han J, Zeng H, Wang H, Li G, Jiang C, Xing Z, Hao Y, Yang F, Hou X. The effect of methylprednisolone prophylaxis on inflammatory monocyte subsets and suppressive regulatory T cells of patients undergoing cardiopulmonary bypass. Perfusion. 2019 Jul;34(5):364-374. doi: 10.1177/0267659118820777. Epub 2019 Jan 9.
Results Reference
derived
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Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
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