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Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

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ClinicalTrials.gov Identifier: NCT01296074
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Heart Valve Diseases Systemic Inflammatory Response Syndrome Drug: Corticosteroid

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Actual Study Start Date : March 2011
Primary Completion Date : April 2011
Study Completion Date : August 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: Corticosteroid
Methylprednisolone will be given during cardiopulmonary bypass.
Drug: Corticosteroid
500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
Other Name: Solu-Medrol


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Valve replacement under cardiopulmonary bypass

Exclusion Criteria:

  • Cardiopulmonary bypass time over 120 minutes
  • Hyperlipidemia
  • Diabetes mellitus
  • Autoimmune diseases
Contacts and Locations

Information from the National Library of Medicine

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


Locations
China, Beijing
Xiaotong Hou
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Beijing Anzhen Hospital
National Natural Science Foundation of China
Investigators
Principal Investigator: Xiaotong Hou, M.D., Ph.D. Beijing Anzhen Hospital, Capital Medical University
More Information

Publications:
Responsible Party: Xiaotong Hou, Chief of Center for Cardiac Intensive Care, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01296074     History of Changes
Other Study ID Numbers: 81070203
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Xiaotong Hou, Beijing Anzhen Hospital:
monocyte
cardiopulmonary bypass
cardiac surgery

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Heart Valve Diseases
Inflammation
Pathologic Processes
Shock
Heart Diseases
Cardiovascular Diseases
Methylprednisolone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents