Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Recruitment status was Not yet recruiting
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Purpose
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 | Intervention |
|---|---|
|
Heart Valve Diseases Systemic Inflammatory Response Syndrome |
Drug: Corticosteroid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response |
- recovery of monocyte subsets [ Time Frame: baseline, day1, 3, 5, 7 postoperative ] [ Designated as safety issue: No ]Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Valve replacement under cardiopulmonary bypass
Exclusion Criteria:
- Cardiopulmonary bypass time over 120 minutes
- Hyperlipidemia
- Diabetes mellitus
- Autoimmune diseases
Contacts and Locations| Contact: Xiaotong Hou, M.D., Ph.D. | +8601064456838 | houxiaotong@yahoo.com.cn |
| China, Beijing | |
| Xiaotong Hou | Not yet recruiting |
| Beijing, Beijing, China, 100029 | |
| Contact: Xiaotong Hou, M.D., Ph.D. +8601064456838 houxiaotong@yahoo.com.cn | |
| Principal Investigator: Xiaotong Hou, M.D., Ph.D. | |
| Principal Investigator: | Xiaotong Hou, M.D., Ph.D. | Beijing Anzhen Hospital, Capital Medical University |
More Information
Publications:
| Responsible Party: | Xiaotong Hou, Beijing Anzhen Hospital, Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT01296074 History of Changes |
| Other Study ID Numbers: | 81070203 |
| Study First Received: | February 14, 2011 |
| Last Updated: | February 14, 2011 |
| Health Authority: | China: Beijing Municipal Science and Technology Commission |
Keywords provided by Capital Medical University:
|
monocyte cardiopulmonary bypass cardiac surgery |
Additional relevant MeSH terms:
|
Heart Valve Diseases Systemic Inflammatory Response Syndrome Heart Diseases Cardiovascular Diseases Inflammation Pathologic Processes Shock Methylprednisolone Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013