Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

Heart Valve Diseases Clinical Trial

Official title:

The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296074
• Other study ID #: 81070203
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: October 17, 2017
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2017
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Valve replacement under cardiopulmonary bypass

Exclusion Criteria:

• Cardiopulmonary bypass time over 120 minutes

• Hyperlipidemia

• Diabetes mellitus

• Autoimmune diseases

Related Conditions & MeSH terms

• Heart Valve Diseases
• Systemic Inflammatory Response Syndrome

Intervention

Drug:
• Corticosteroid
500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.

Locations

Country	Name	City	State
China	Xiaotong Hou	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

Bourbon A, Vionnet M, Leprince P, Vaissier E, Copeland J, McDonagh P, Debré 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, day1, 3, 5, 7 postoperative