Clinical trial NCT01296074: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Systemic Inflammatory Response Syndrome
Keywords: monocyte
cardiopulmonary bypass
cardiac surgery
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2011-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Valve replacement under cardiopulmonary bypass

Exclusion Criteria:

* Cardiopulmonary bypass time over 120 minutes
* Hyperlipidemia
* Diabetes mellitus
* Autoimmune diseases

Primary outcomes:
measure: recovery of monocyte subsets
timeFrame: baseline, day1, 3, 5, 7 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiaotong Hou
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Xiaotong Hou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.